[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Mental Health (NIMH)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":596},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,50,76,99,128,152,175,198,227,253,272,293,315,340,359,383,405,431,450,467,486,511,530,551,574],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100651778","augmenting-parent-management-training-for-child-temper-outbursts-using-a-digital-tool-100651778",false,"NCT07764536","Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool","Augmenting Parent Management Training With Naturalistic Skills for Child Temper Outbursts Using a Digital Tool","* INCLUSION CRITERIA:\n\nInclusion Criteria for Youth:\n\nTo be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:\n\n* Enrollment into protocol 01-M-0254 for screening purposes\n* Age 8-13 years (8 years 0 months through 13 years 11 months)\n* Parent\u002Fguardian and\u002For child reports irritability as a primary clinical concern. Specifically, compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property. This criterion is assessed based on the clinical interview conducted with parent\u002Fguardian and child after consenting into protocol 01-M-0254 for screening.\n* On the basis of record review and interviews with child and parent or guardian, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e., CGI-S of 3 or more). This criterion is assessed based on the clinical interview conducted with parent\u002Fguardian and child after consenting into protocol 01-M-0254 for screening.\n* Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement.\n\n  --This study uses English-language manualized PMT. The PMT intervention materials, digital tool, therapist and rater training and supervision procedures, fidelity ratings, and outcome measures are currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Enrolling non-English speakers can introduce a confound to our research objectives around feasibility, symptom and behavior change, and acceptability and fidelity. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n* At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent.\n* The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document.\n\nInclusion Criteria for Parent or Guardian:\n\nTo be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:\n\n* Enrollment into 01-M-0254 for screening purposes\n* Parent or guardian of a child eligible for this protocol that can attend 12 PMT sessions and is willing to use the digital tool\n* Fluent in English after consenting into protocol 01-M-0254 as determined through clinical judgement\n* Ability of parent or guardian to understand the consent form and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for Youth:\n\nAll screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n* Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments\n* IQ \\\u003C 70\n* Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nExclusion Criteria for Parent or Guardian:\n\nAll screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n* IQ \\\u003C 70 as assessed via a neuropsychological assessment or via assessment by trained clinical staff\n* Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n* Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment but not including self-help groups).","ALL","8 Years","13 Years",{"count":21,"type":22},200,"ESTIMATED","OBSERVATIONAL","Background:\n\nPediatric disruptive behavior disorders (DBDs) are characterized by severe irritability, anger, and temper outbursts. The primary way to treat children with DBDs is parent management training (PMT). PMT teaches parents how to reward desired behaviors and not to reward undesired ones. Researchers want to find out if a smartphone app can help parents apply these skills more effectively.\n\nObjective:\n\nTo test a smartphone app to enhance PMT.\n\nEligibility:\n\nChildren aged 8 to 13 years with DBDs. A parent or guardian is also needed.\n\nDesign:\n\nParents will have 12 weekly sessions of PMT. PMT teaches them how to manage their child s mood and behaviors. Parents will learn to actively ignore, praise, set limits, and handle temper outbursts. PMT can be either in person or via video. Sessions last 30 to 60 minutes. They will be video and audio recorded.\n\nParents will be divided into 2 groups. Only 1 group will download a smartphone app. The app helps parents practice PMT skills. It offers videos, a resource library, and alerts when a child may be at risk for various behaviors.\n\nAll parents will be prompted every day to answer questions about their child s mood and their own behavior. These will continue until 12 weeks after their last PMT session.\n\nChildren will also answer questions on their phone daily for 1 week at a time. They will do this on 3 different weeks, each about 2 months apart. They will also have check-ins by phone every 2 weeks for up to 6 months.\n\nParents will have follow-up calls 3, 6, and 12 months after they finish PMT.",[26,27,28,29],"Disruptive Behavior Disorders","Conduct Disorder","Oppositional Defiant Disorder","Attention-deficit\u002FHyperactivity Disorder",[26,31,32,33,34,35,36],"Parent Management Training","Children","Parents","Digital tool","Irritability","Temper outbursts","NOT_YET_RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-08-26",{"date":45,"type":22},"2037-12-31",{"name":47,"class":48},"National Institute of Mental Health (NIMH)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":75,"locationsCount":49},"100641449","psychotherapy-for-irritability-in-youth-comparing-active-treatment-to-nonactive-psychoeducation-supportive-psychotherapy-100641449","NCT07640802","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy","* INCLUSION CRITERIA FOR YOUTH:\n\n  1. Age 8-16.5 years\n  2. Caregiver and\u002For child reports irritability as a primary clinical concern. Specifically, compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property.\n\n  2a. Such events occur, on average, at least three times a week.\n\n  2b. This irritability is impairing in at least two of three domains (home, school, peers)\n\n  3\\. Patients must be fluent in English\n\n  3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are\n\ncurrently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance\u002Fsupport are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n\n4\\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n\n5\\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment.\n\nINCLUSION CRITERIA FOR PARENT:\n\n1. Parent of a child eligible for this protocol that can attend 12 parent sessions\n2. Fluent in English\n\nEXCLUSION CRITERIA FOR YOUTH:\n\nParticipants will be screened to exclude participants who would not be able to engage in psychotherapy.\n\n1. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments.\n2. IQ \\\u003C 70 as assessed by a WASI or assessment by trained clinical staff\n3. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nEXCLUSION CRITERIA FOR PARENTS:\n\n1. IQ \\\u003C 70\n2. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n3. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).","17 Years",{"count":59,"type":22},410,"Background:\n\nIrritability is defined as proneness to anger that may impair a person's ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.\n\nObjective:\n\nTo test different types of therapy for children and teens with severe irritability.\n\nEligibility:\n\nPeople aged 8 to 16.5 years with severe irritability. Their parents are also needed.\n\nDesign:\n\nParticipants will have 28 study visits in 18 months.\n\nThey will have a baseline visit. They will answer questions about their mood, behavior, and daily life.\n\nAll parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.\n\nEach parent and child will have 1 of 3 therapy types:\n\nExposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.\n\nManagement therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.\n\nPsychoeducation\u002Fsupportive psychotherapy (child and\u002For parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.\n\nSessions may be videotaped. Participants may opt out of being recorded.\n\nParticipants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.",[35,62,28,63],"Disruptive Mood Dysregulation Disorder","Attention Deficit Hyperactivity Disorder",[35,31,65,66,32,67,68,69,70,71],"Psychosocial Treatment","Exposure Therapy","ANGER","Pediatric","Cognitive Behavioral Therapy","Psychoeducation","Supportive Therapy",{"date":40,"type":41},{"date":43,"type":22},{"date":45,"type":22},{"name":47,"class":48},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":57,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":49},"100636498","role-of-theta-frequency-oscillations-in-proactive-and-reactive-control-processes-in-youth-with-attention-deficit-hyperactivity-disorder-adhd-and-obsessive-compulsive-disorder-ocd-100636498","NCT07566468","Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)","* INCLUSION CRITERIA:\n\n  1. Ability to provide informed assent and parent consent\n  2. Age: 10-17 years\n  3. ADHD Group: Diagnosis of ADHD based on DSM-5 criteria\n\n     OCD Group: Diagnosis of OCD based on DSM-5 criteria\n\n     HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria\n  4. Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ \\> 70.\n  5. Normal or corrected to normal vision\n\nEXCLUSION CRITERIA:\n\nParticipants will be screened to exclude participants in whom MRI or EEG might result in increased risk of side effects or complications or whose data would not be scientifically valid.\n\n1. Non-English Speakers\n2. Pregnancy\n3. Any implant, prosthesis or alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or EEG or that would produce an artifact that would compromise the integrity of data;\n4. Active or History of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments;\n5. Individuals currently taking stimulant medications who cannot tolerate being off their medication for up to 48 hours prior to the study visit and experience an exacerbation of symptoms that necessitates the resumption of medication prior to completion of the study visit.\n6. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n7. For the HV group, any impairing current psychiatric diagnosis.","10 Years",{"count":84,"type":22},110,"Background:\n\nAttention deficit hyperactivity disorder (ADHD) is common in children. It can cause problems with attention and the ability to control actions and impulses. Obsessive compulsive disorder (OCD) is less common in children but not rare. It involves ongoing thoughts, urges, impulses, and repeated behaviors. Researchers want to study differences in brain activity between healthy children, those with ADHD, and those with OCD.\n\nObjective:\n\nTo learn more about how the brain controls thinking and behavior.\n\nEligibility:\n\nPeople aged 10 to 17 years with ADHD, OCD, or neither.\n\nDesign:\n\nParticipants will have 3 to 10 clinic visits in up to 1 year. Each visit will last 2 to 3 hours.\n\nThree visits are required:\n\nBehavioral. Participants will complete a computer task. Their mood, memory, attention, and thinking skills will be tested.\n\nEEG. Participants will undergo electroencephalography (EEG) to measure signals in their brain. Small electrodes will be placed on the scalp. A cap will be stretched over the head. Signals will be recorded while participants rest or do tasks on a computer.\n\nMRI. Participants will have a magnetic resonance imaging scan (MRI). They will lie on a table that rolls into a tube. The MRI will take pictures of their brain while they do tasks on a computer.\n\nSeven more visits are optional. These include 2 more EEG visits and 2 more MRI visits.\n\nThree will be magnetoencephalography (MEG) visits: MEG measures small magnetic field changes in the brain. A helmet with sensors will be placed on the head. Brain changes will be recorded while participants rest or do tasks on a computer.",[87,88,89],"ADHD","Obsessive Compulsive Disorder (OCD)","Healthy Volunteer",[91,92,93],"EEG","MRI","fMRI",{"date":40,"type":41},{"date":43,"type":22},{"date":97,"type":22},"2029-05-31",{"name":47,"class":48},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":49},"100605983","pet-imaging-of-phosphodiesterase-4-pde4-in-volunteers-with-alzheimer-disease-ad-or-mild-cognitive-impairment-mci-100605983","NCT07169630","PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)","PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)","* INCLUSION CRITERIA:\n\nParticipants will be referred by a physician with the suspected diagnosis of AD or MCI. However, the PI of this protocol will provide the final diagnosis. For this reason, this protocol will have just one consent form for participants suspected of having either AD or MCI.\n\nAD and MCI Study Groups:\n\nParticipants must meet all the following criteria:\n\n* Aged 50 or older.\n* Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n* Have been diagnosed by a neurologist or psychiatrist with MCI or AD.\n* Be in good general health as evidenced by medical history and physical examination.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nHealthy Volunteers:\n\nParticipants must meet all the following criteria:\n\n* Aged 50 or older.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth the study groups will be excluded if they meet any of the following criteria:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n* Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n* Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the volunteer and\u002For caregiver during the screening visit.\n* Participants must not have substance use disorder or alcohol use disorder.\n* Participants should not be under treatment or previously treated with an amyloid antibody such as lecanemab.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n* Pregnancy or breast feeding.\n* HIV infection.\n* Non-English speaking participants.\n\nExclusion of Children:\n\nInclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.\n\nExclusion of Pregnant or Breastfeeding Women:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will not require contraception for this protocol to allow participants autonomy in medical decision-making. However, while we will not require contraception for woman of childbearing potential, we will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant\n\nExclusion of Participants who are HIV Positive:\n\nPersons with HIV infection are excluded because HIV infection itself may change cAMP signaling.\n\nExclusion of Non-English-Speaking Participants:\n\nNon-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator.",true,"50 Years","100 Years",{"count":110,"type":22},90,"INTERVENTIONAL",[113],"PHASE1","Background:\n\nAbout 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI.\n\nObjective:\n\nTo test whether medical imaging using a new radiotracer (\\[18F\\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI.\n\nEligibility:\n\nPeople aged 50 years and older with AD or MCI. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits with 3 imaging scans of the brain.\n\nThey will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory.\n\nParticipants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each.\n\nParticipants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....",[116,117,118],"Alzheimer s Disease","Mild Cognitive Impairment","Healthy",[120,121],"18F-PF-06445974","PET Imaging","RECRUITING",{"date":40,"type":41},{"date":43,"type":22},{"date":126,"type":22},"2030-04-11",{"name":47,"class":48},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":4,"leadSponsor":151,"locationsCount":49},"100054408","studies-of-blood-flow-to-the-brain-during-thought-100054408","NCT00001360","Studies of Blood Flow to the Brain During Thought","Regional Cerebral Blood Flow Studies of Object Perception, Identification, Localization, and Memory","* INCLUSION CRITERIA:\n* Healthy adults, with at least a high school education, aged 18 to 65 years, will be recruited to participate in the study.\n* Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded if they:\n\n* have evidence of, or a history of:\n* major medical, neurological or psychiatric illness\n* serious head injury\n* learning disability-drug or alcohol abuse or dependence in the past 3 months, except nicotine\n\n-are taking prescription drugs or supplements that may affect brain function-\n\n-have serious vision or hearing problems\n\nIn addition to the above, additional exclusion criteria apply for all MRI studies:\n\n* Female subjects who are pregnant or have a positive pregnancy test 24 hours prior to an experiment will be excluded from neuroimaging studies.\n* All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded from MRI scanning experiments because of possible risks during MRI scanning. Those whose history is suggestive of such a problem will also be excluded from the MRI portion of the experiments. They may still participate in the behavioral and MEG experiments.\n* Subjects unable to lie flat on their back for up to 3 hours may not be eligible to participate in MRI scans.","18 Years","65 Years",{"count":138,"type":22},4100,"The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks.\n\nThis study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visual perception, visual recognition, and memory....",[89],[142,143,144,145,146,147],"Cognition","Vision","Cortex","Visual Processing","Magnetic Resonance Imaging","Natural History",{"date":40,"type":41},{"date":150,"type":41},"1993-09-17",{"name":47,"class":48},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":108,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":4,"leadSponsor":174,"locationsCount":49},"100139549","top-down-attentional-control-of-visual-processing-100139549","NCT01087281","Top-Down Attentional Control of Visual-Processing","* INCLUSION CRITERIA:\n\nAll Subjects\n\n1. All subjects will be 18 years of age or older and have at least a high school education.\n2. Capacity to provide their own informed consent, understand and cooperate with study procedures.\n3. Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nPatients:\n\n1. Unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.\n2. At least three months post-stroke, lobectomy and or neurosurgical resection.\n\nHealthy volunteers:\n\n1\\. Neurologically normal and in good general health.\n\nEXCLUSION CRITERIA\n\nPatients:\n\n1. Any neurological or psychiatric disorder not related to the focal lesion (e.g., epilepsy, schizophrenia, etc.). Epilepsy patients who have undergone surgery and as a result are seizure free may be recruited.\n2. Previous head injury.\n3. Present or past (within past 6 months) drug or alcohol abuse or addiction as determined by a qualified study neurologist\u002Fpsychiatrist.\n4. Radiation treatment to the brain during a three-month period prior to the experiment.\n\nHealthy volunteers:\n\n1. Any neurological or psychiatric disorder (e.g., epilepsy, schizophrenia, etc.)\n2. Previous head injury.\n3. Present or past (within past 6 months) drug or alcohol abuse or addiction based on DSM-5 criteria as determined during History and Physical exam.\n\nADDITIONAL EXCLUSION CRITERIA FOR MRI SCAN:\n\nPatients and Healthy volunteers:\n\n1. Women who are pregnant and women of child-bearing potential who refuse to undergo a urine pregnancy test will be excluded from fMRI experiments.\n2. Subjects who have contraindications to MRI scanning will be excluded from fMRI experiments but included in cognitive experiments. These contraindications include:\n\n   1. central nervous system aneurysm clips;\n   2. implanted neural stimulator;\n   3. implanted cardiac pacemaker or defibrillator;\n   4. cochlear implant;\n   5. ocular foreign body (e.g., metal shavings);\n   6. insulin pump;\n   7. metal shrapnel or bullet;\n   8. any implanted device that is incompatible with MRI.\n3. Conditions that preclude scanning, e.g., morbid obesity, claustrophobia.\n\nADDITIONAL EXCLUSION CRITERIA FOR TASKS INVOLVING COLOR DISCRIMINATION:\n\nPatients and Healthy volunteers:\n\nSubjects who are determined during screening or history and physical exam to be color-blind will be excluded from participating in certain tasks that involve color discrimination.",{"count":159,"type":22},300,"Background:\n\n\\- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.\n\nObjectives:\n\n\\- To better understand the areas of the brain involved in paying attention to things that are seen.\n\nEligibility:\n\n\\- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.\n\nDesign:\n\n* The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours.\n* Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit.\n* On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests.\n* Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors.\n* Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity.\n* During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.",[162,163,93],"Focal Brain Lesion","Focal Lesions",[165,166,163,167,168,147,162,89,169],"Visual Attention","Visual Cortex","Neurological Disorder","Functional Magnetic Resonance Imaging (fMRI)","HV","2026-08-19",{"date":38,"type":41},{"date":173,"type":41},"2012-07-23",{"name":47,"class":48},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":111,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":49},"100645701","pet-imaging-of-noradrenergic-transmission-in-the-brain-100645701","NCT07686393","PET Imaging of Noradrenergic Transmission in the Brain","* INCLUSION CRITERIA:\n\n  1. Aged 18 years or older.\n  2. Must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies.\n  3. Be healthy based on medical history, physical examination, and laboratory testing.\n  4. Able to understand and willingness to provide informed consent.\n  5. Willingness to complete all study procedures including MRI tests.\n  6. Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n  7. Agree to adhere to the lifestyle considerations\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n2. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.\n3. Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n4. HIV infection.\n5. Pregnancy or breastfeeding.\n6. Must not have substance use disorder or alcohol use disorder.\n7. Unable to travel to the NIH.\n8. Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n9. Taking medications reported to have significant binding to alpha-1 adrenoceptors, medications that that alter norepinephrine release, or medications that lower blood pressure including antihypertensives, diuretics, or phosphodiesterase-5(PDE-5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) within five elimination halflives prior to any \\[11C\\]ARMI PET scan.\n10. Known hypersensitivity to quinazoline-class medications (e.g., prazosin), defined as any prior allergic or clinically significant adverse reaction requiring discontinuation or medical evaluation.\n11. Blood donation within 8 weeks (2 months) before study participation, or unwillingness to avoid blood donation for 8 weeks (2 months) after the study.","105 Years",{"count":183,"type":22},40,[113],"Background:\n\nResearchers have developed a new radioactive tracer (11C-ARMI). A tracer is a drug that attaches itself to other chemicals in the body and lights up so that the chemicals can be seen in imaging scans. The new tracer may be able to help them with many diseases, such as Alzheimer s disease and Parkinson s disease. Researchers want to test the new tracer in healthy people.\n\nObjective:\n\nTo test a new tracer (11C-ARMI) during imaging scans of the brain and body in healthy people.\n\nEligibility:\n\nHealthy people aged 18 years and older. They must have been screened under protocols 01-M-0254 or 17M0181.\n\nDesign:\n\nAll participants will have a positron emission tomography (PET)\u002Fcomputed tomography (CT) scan. Before the scan, they will have blood and urine tests and a test of their heart function. The tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.\n\nSome participants will have a PET\u002FCT scan of their whole body. They will need only 1 visit.\n\nSome participants will have a PET\u002FCT scan of only their brain. They will have up to 2 visits. On the second visit, they will have a magnetic resonance imaging (MRI) scan of the brain. For the MRI, they will lie on a table that slides into a cylinder. The MRI uses magnetic fields to create images of the inside of the body.\n\nParticipants will receive a follow-up call to check on their well-being after their PET\u002FCT scans.",[118],[188,189,190,118],"Positron Emission Tomography (PET) Imaging","11C-ARMI","Alpha-1A Adrenoreceptor ( 1A-AR)","2026-08-18",{"date":170,"type":41},{"date":194,"type":41},"2026-08-14",{"date":196,"type":22},"2030-02-20",{"name":47,"class":48},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":49},"100410940","developing-brain-impulsivity-and-compulsivity-100410940","NCT04631042","Developing Brain, Impulsivity and Compulsivity","An Observational Study of the Developing Brain, Impulsivity and Compulsivity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Must be between 6 and 80 years of age.\n3. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. Very premature birth (i.e., birth before 32 weeks of gestational age).\n3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).\n4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).\n5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.\n6. Pregnant women.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data\u002Fassessments.\n\nAdditional exclusion criteria for optional MRI procedure:\n\n1\\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).","6 Years","80 Years",{"count":208,"type":22},1100,"Background:\n\nImpulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role.\n\nObjective:\n\nTo learn about genetic \\& brain features that explain why levels of impulsivity and compulsivity vary across people.\n\nEligibility:\n\nPeople ages 6 - 80\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys.\n\nParticipants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken.\n\nParticipants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game.\n\nParticipants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study.\n\nParticipants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.",[211,212,27,63,213],"Typical Development","Obsessive Compulsive Disorder","Autism Spectrum Disorder",[215,216,147,217,218,219,220],"Neurodevelopmental disorder","Twin","Heritability","Glutamate","developmental trajectory","Brain Connectivity",{"date":170,"type":41},{"date":223,"type":41},"2022-09-30",{"date":225,"type":22},"2031-12-31",{"name":47,"class":48},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":111,"phases":236,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":49},"100586841","phase-1-pet-imaging-of-cyclooxygenase-1-in-participants-with-neurological-manifestations-of-post-acute-sequelae-of-sars-cov-2-infection-pasc-100586841","NCT06920628","PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)","* INCLUSION CRITERIA:\n\nPatients: To be eligible for this study, Neuro-PASC participants must meet all of the following criteria:\n\n* Aged 18 to 70 years of age.\n* Participants must be in good general health as evidenced by medical history and physical examination.\n* Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* Participants must have undergone a screening assessment under protocol #000089, Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health or #000711 Immunotherapy for Neurological Post-Acute Sequelae of SARSCoV-2 (INPASC) and determined to have neuro-PASC.\n* Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Volunteers: To be eligible to participate in this study, healthy volunteers must meet all of the following criteria:\n\n* Aged 18 to 70 years of age.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and\u002For testing.\n* Participants must be at least six weeks out since the onset of SARS-CoV-2 symptoms with no fever for at least one week.\n* Participants must report having at least one prior SARS-CoV-2 infection.\n* Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with Neuro-PASC who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing based on individual clinical judgement. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two times the upper limit or lower values, as per the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n* Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to each PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken within one month prior to each PET scan.\n* Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits as determined by the study team.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours,including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Pregnancy or Breastfeeding Women.\n* HIV Infection.\n\nHealthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for two weeks prior to the PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g., methotrexate) must not have been taken within one month prior to the PET scan.\n* Participants with an active SARS-CoV-2 infection.\n* Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Pregnancy or Breastfeeding Women.\n* HIV Infection.","70 Years",{"count":235,"type":22},60,[113],"Background:\n\nSARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders.\n\nObjective:\n\nTo see if a radioactive tracer (\\[11C\\]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain.\n\nEligibility:\n\nAdults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits.\n\nParticipants will be screened. They will have blood tests and a test of their heart function.\n\nThey will have imaging scans:\n\nMagnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain.\n\nPositron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours.\n\nStudy involvement is 11 to 14 weeks....",[239,240],"Long COVID","Post Acute Sequelae of COVID-19",[242,243,244,245],"Inflammation","COVID","SARS","Neuro-PASC","2026-08-15",{"date":191,"type":41},{"date":249,"type":41},"2025-06-18",{"date":251,"type":22},"2029-02-22",{"name":47,"class":48},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":111,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":49},"100583275","phase-1-assessment-of-11c-jmj-129-for-imaging-pde4d-in-brain-and-whole-body-of-healthy-volunteers-100583275","NCT06874205","Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers","* INCLUSION CRITERIA:\n* Aged 18 years or older.\n* Participants must have undergone a screening assessment under protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants.\"\n* Healthy based on medical history, physical examination, and laboratory testing.\n* Able to provide informed consent.\n* Willing and able to complete all study procedures including MRI tests.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Any current Axis I diagnosis.\n* History of neurologic illness or injury with the potential to affect study data interpretation.\n* History of seizures, other than in childhood and related to fever.\n* Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.\n* Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n* HIV Infection.\n* Pregnancy or breast feeding.\n* Participants must not have substance use disorder or alcohol use disorder.\n* Unable to travel to the NIH.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n\nAdditional exclusions for participants receiving disulfiram:\n\nParticipants will be excluded if any of the following apply:\n\n1. Current use of, or use within the past 14 days, of metronidazole or paraldehyde.\n2. Consumption of alcohol or alcohol-containing products within 24 hours prior to disulfiram administration, or inability\u002Funwillingness to abstain from alcohol containing products for 14 days after administration.\n3. History or presence of severe myocardial disease or coronary occlusion. Current or past history of psychotic disorders.\n4. Known hypersensitivity to disulfiram or other thiuram derivatives.","101 Years",{"count":183,"type":22},[113],"Background:\n\nPDE4D is a protein in the body that plays a role in thinking and depression. This protein may play a major role in disorders such as Alzheimer disease or major depressive disorder. To learn more about these disorders, researchers want to be able to detect levels of PDE4D in the brain. 11C-JMJ-129 is a new radiotracer (a radioactive substance that highlights parts of the body during imaging scans) that was developed to attach only to PDE4D. However, early human studies showed that the tracer may break down in the body and create byproducts that interfere with the brain signal, making the results harder to interpret. This study will test whether a medication called disulfiram can improve PET imaging with 11C-JMJ-129. Disulfiram blocks an enzyme in the body that may be responsible for breaking down the tracer. By reducing this breakdown, the study aims to improve the quality and accuracy of brain images. The results may help researchers better measure PDE4D in the brain and support future studies of brain disorders.\n\nObjective:\n\nTo test the new radiotracer 11C-JMJ-129, with and\u002For without disulfiram pretreatment during imaging scans in healthy volunteers.\n\nEligibility:\n\nHealthy people aged 18 years and older who had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will have 1 to 4 clinic visits.\n\nParticipants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function.\n\nParticipants will undergo 1 or more of these scans:\n\nA positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube placed in a vein in the arm. Participants will lie on a table while a donut-shaped machine passes over them. Blood will be drawn from the arm during this scan.\n\nIn Phase 5, disulfiram (500 mg orally) will be administered approximately 20 hours before the post-disulfiram PET scan\n\nA magnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube.\n\nA PET scan of the brain. These participants will be injected with the radiotracer. They will lie on a table with their head in the scanner.\n\nParticipants will be called within 3 days after each PET scan for a check on their health.",[118],[265,121],"11C-JMJ-129",{"date":191,"type":41},{"date":268,"type":41},"2025-04-11",{"date":270,"type":22},"2029-02-05",{"name":47,"class":48},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":233,"enrollmentInfo":278,"targetDuration":4,"studyType":111,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":49},"100577229","phase-1-pet-imaging-of-phosphodiesterase-4b-pde4b-in-alcohol-use-disorder-100577229","NCT06795581","PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder","* INCLUSION CRITERIA:\n\n  1. Age 18-70 years\n  2. Willingness to complete the study including MRI tests.\n  3. Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n  4. Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n  5. Participants must agree to adhere to the lifestyle considerations.\n  6. Enrolled in protocol 14-AA-0181\n\nEXCLUSION CRITERIA:\n\nClinically significant abnormalities on laboratory testing beyond that expected in participants during alcohol withdrawal. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n\n1. Clinically significant abnormalities on EKG.\n2. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n3. Participants with a breath alcohol level (BAL) past 0.08.\n4. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n5. Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission.\n6. HIV infection.\n7. Pregnancy.\n8. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n9. Have an inability to lie flat and\u002For lie still on the camera bed for two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n10. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n11. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.",{"count":279,"type":22},30,[113],"Background:\n\nPeople with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD.\n\nObjective:\n\nTo find out (1) if PDE4B levels are lower in people who are withdrawing from AUD and (2) if their PDE4B levels go up after they abstain from alcohol for 3 to 4 weeks.\n\nEligibility:\n\nAdults aged 18 to 70 years with AUD. They must be enrolled in protocol 14-AA-0181.\n\nDesign:\n\nParticipants enrolled in protocol 14-AA-0181 will stay in the clinic for 3 to 4 weeks for alcohol withdrawal. During this stay, they will have some added procedures for the current study.\n\nWithin the first week, participants will have a positron emission tomography (PET) scan of the brain. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer will be injected through the catheter. This tracer binds to PDE4B and makes it easier to see the protein in the brain. For the scan, participants will lie on a table that slides into a doughnut-shaped machine.\n\nParticipants will have a second PET scan toward the end of their stay in the clinic.\n\nParticipants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube....",[283],"Alcohol Use Disorder",[121,285,286],"Alcohol Use Disorder (AUD)","Phosphodiesterase-4B (PDE4B)",{"date":191,"type":41},{"date":289,"type":41},"2025-03-20",{"date":291,"type":22},"2029-01-31",{"name":47,"class":48},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":111,"phases":302,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100553284","early-phase-1-study-brain-mechanisms-of-frustration-with-magnetoencephalography-in-healthy-volunteers-100553284","NCT06484088","Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers","Characterizing the Brain Circuitry and Neural Activity Mediating Frustration","-INCLUSION CRITERIA:\n\nThis study will include adult healthy volunteers.\n\n* Age: 18-55\n* Consent: can give consent\n* Speak and read English\n\n  --The instruments have not been validated in other languages.\n* At the NIH site, previously screened through other NIH protocols such as protocol 01-M-0254, 17-M-0181, and 93-M-0170 and determined eligible as healthy volunteers.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n-Any serious medical condition\n\n* History, physical exam, or laboratory testing including drug abuse screen.\n\n  -Prescription and over-the-counter medications and dietary supplements with psychoactive properties (e.g., St. John's Wort, Melatonin, Valerian)\n\n  -Any condition that interferes with MRI or MEG\\*\\*\n* History\n\n  -Any current psychiatric diagnosis\n* SCID-V, clinical assessment, or history.\n\n  -Pregnancy\n* Pregnancy testing will be done before all MRIs.\n\n  -People who work on night shifts\n* History\n\n  -Drug use\n* Subjects with drug use or positive drug screen more than two years ago are eligible for participation.\n\n  -Need to wear eye glasses to work with computers\\*\n* History\n\n  -Need to wear contact lenses to work with computers\\*\\*,\\*\\*\\*\n* History\n\n  -Dental retainer\\*\\*\n* Subjects wearing removable dental retainers are eligible for participation\n\n  * Eye glasses create artifacts in MEG and their rigid shape does not fit well in the MEG scanner. The MEG core has plastic optometry lenses that can be placed in paper frames. However, the paper frames need to be secured with tape which makes wearing them very uncomfortable, potentially promoting negative emotion and reducing the reliability of facial expression analysis.\n\n    * Only applies to the NIH site.\n\n      * Contact lenses create artifacts that interfere with eye-tracking.","55 Years",{"count":110,"type":22},[303],"EARLY_PHASE1","Background:\n\nIrritability can be defined as an unusually strong response to frustration; these responses may include severe temper outbursts and a constant grumpy mood. Irritability is a common symptom of many mental health disorders. Little is known about how the brain responds to frustration, and few treatments are available for this problem. Researchers want to know more about how the brain responds to frustration.\n\nObjective:\n\nTo learn how the brain responds to frustration.\n\nEligibility:\n\nHealthy adults aged 18 to 55 years. They must have been screened through studies 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will have up to 3 study visits in 2 months. Each visit will last up to 4 hours.\n\nVisit 1: Participants will be screened. They will have a physical exam. They will complete questionnaires about how often and how easily they get angry or grumpy. They will be trained to use a device that measures hand grip.\n\nVisit 2: Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Padding will hold their head still.\n\nVisit 3: Participants will undergo magnetoencephalography (MEG). A cone with detectors will be lowered over their head while they are seated. The MEG will measure the magnetic fields in the participant s brain both while they are resting and while they are doing the frustration task. For the task, they will hold a grip device in each hand. They will use the devices to pick 1 of 2 doors on a computer screen. The task has 3 parts. The participant s face will be filmed during this task.",[35],[307],"Healthy volunteers, Frustration, Magnetoencephalography",{"date":191,"type":41},{"date":310,"type":41},"2025-02-21",{"date":312,"type":22},"2027-08-31",{"name":47,"class":48},2,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":321,"targetDuration":4,"studyType":111,"phases":323,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":49},"100435446","characterization-of-an-optically-pumped-magnetometer-opm-magnetoencephalography-meg-array-100435446","NCT04950309","Characterization of an Optically Pumped Magnetometer (OPM) Magnetoencephalography (MEG) Array","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18-65\n4. In good general health as evaluated according to protocol 17-M-0181\n5. Completed a magnetic resonance imaging (MRI) scan under 17-M-0181\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Participants excluded from 17-M-0181 will be excluded from this protocol\n2. Metal in the body which would cause artifacts on MEG recordings",{"count":322,"type":22},75,[324],"NA","Background:\n\nBrain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.\n\nObjective:\n\nTo develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.\n\nEligibility:\n\nHealthy people ages 18-65 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.\n\nDesign:\n\nParticipants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.\n\nFor the MEG, 3 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.\n\nFor the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.\n\nFor both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).\n\nResearchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.\n\nParticipation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....",[327],"Normal Physiology",[329,330,331,332,333],"Imaging","biomagnetism","somatotopy","optically pumped magnetometer","Magnetoencephalography",{"date":191,"type":41},{"date":336,"type":41},"2022-05-12",{"date":338,"type":22},"2027-08-01",{"name":47,"class":48},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":233,"enrollmentInfo":346,"targetDuration":4,"studyType":111,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":358,"locationsCount":49},"100407245","phase-1-pet-imaging-of-cyclooxygenase-in-participants-with-major-depressive-disorder-mdd-100407245","NCT04582916","PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible for this study, MDD participants must meet all of the following criteria:\n\n1. Aged 18 to 70 years old.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n3. Participants must be in good general health as evidenced by medical history and physical examination.\n4. Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n5. All participants must have undergone a screening assessment under protocol 01M0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .\n6. Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).\n7. Participants must have an initial score on the MADRS greater than or equal to 18 or HAM-D greater than or equal to 15 within one week of study entry.\n8. Participants must be experiencing an MDE lasting at least four weeks.\n9. Unmedicated participants in both Groups must be medication-free for at least two weeks (5 weeks for aripirazole, brexpiprazole, fluoxetine) prior to first screen visit. Medications will not be discontinued for the purpose of this study.\n10. Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n11. Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:\n\n1. Aged 18 to 70 years old.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n3. Able to provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with MDD who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n2. Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics. Medicated participants in Group B may continue their therapy.\n3. Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.\n4. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.\n5. Participants with a history of DSM-5 substance use disorder (except for caffeinei or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily lfe.\n6. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n7. Participants who have a history of aggressive behavior towards others.\n8. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n9. Participants seeking treatment or a change in treatment and may be referred to the community or to another research study.\n10. Are unable to travel to the NIH.\n11. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n12. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n13. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n14. Pregnancy.\n15. HIV Infection.\n16. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nHealthy controls who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n2. Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics.\n3. Participants should not have taken NSAIDs for two weeks prior to the PET scan. Aspirin, corticosteroids, or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.\n4. Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n5. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n9. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n10. Pregnancy.\n11. HIV Infection.\n12. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nEXCLUSION OF CHILDREN:\n\nBecause this protocol has more than minimal risk from radiation exposure without possibility of direct benefit, inclusion of children is not appropriate.\n\nEXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk.\n\nEXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE:\n\nPersons with HIV infection are excluded because HIV infection itself may cause neuroinflammation, and we wish to specifically study the effect of depression on neuroinflammation.\n\nEXCLUSION OF NON ENGLISH SPEAKING PARTICIPANTS:\n\nNon-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator.",{"count":347,"type":22},64,[113],"Background:\n\nResearchers developed \\[11C\\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group.\n\nObjective:\n\nTo determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).\n\nEligibility:\n\nPeople aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years.\n\nDesign:\n\nGroup A: MDD participants will be studied with the same dose of \\[11C\\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \\[11C\\]PS13 and compared to healthy volunteers..\n\nhttps:\u002F\u002Fnimhcontent.nimh.nih.gov\u002Fstart\u002Fsurveys\u002F?s=TJW4RA4WN3LDD988",[351],"Depression",[121,242,353,351],"Cyclooxygenase-2",{"date":191,"type":41},{"date":356,"type":41},"2021-07-20",{"date":126,"type":22},{"name":47,"class":48},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":106,"sex":17,"minAge":365,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100315598","characterization-and-treatment-of-adolescent-depression-100315598","NCT03388606","Characterization and Treatment of Adolescent Depression","* INCLUSION CRITERIA:\n* Youths who meet DSM 5 criteria for Major Depressive Disorder (Group 1)\n\nInclusion criteria for Youth with MDD (all must be met):\n\n* Ages 11-17 at the time of enrollment in Characterization;\n* Current diagnosis of DSM-5 Major Depressive Disorder (within the last six months from assessment) which are:\n* Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.\n\n  * Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, \"down in the dumps,\"or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.)\n  * Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing.\n  * Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month) or decrease or increase in appetite nearly every day.\n  * Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day\n  * Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day\n  * Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual).\n  * Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings).\n  * Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g., appears easily distracted, complains of memory difficulties).\n  * Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide\n* Symptoms cause clinically significant distress or impairment in social, occupational\u002Facademic, or other important areas of functioning.\n* The episode is not attributable to the physiological effects of a substance or to another medical condition.\n\nINCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n* Adolescent Healthy Volunteers (Group 3a)\n\n  * Youth 11 to 17 years of age at time of enrollment in Characterization\n  * the adolescent must be competent to assent; parents must be able comprehend and provide permission for their child (consent).\n  * Participants will be willing to participate in NIMH IRB approved research protocols. Minors will be asked to sign assent forms and their parents will sign the consent form.\n  * Participants will be willing to undergo an evaluation, which may include a psychiatric interview, review of medical history (including Tanner staging for minors), and pregnancy testing.\n  * Speaks English.\n  * Have an identified primary care clinician.\n* Adult Healthy Volunteers (Group 3b)\n\n  * Adults 18 to 30 years of age at time of enrollment in Characterization\n  * Subjects must be competent to consent.\n  * Participants will be willing to participate in NIMH IRB approved research protocols.\n  * Participants will be willing to undergo an evaluation, which may include a psychiatric interview, review of medical history, and pregnancy testing (for females).\n  * Speaks English.\n  * Has an identified primary care clinician.\n\nINCLUSION CRITERIA FOR PARENTS OF ENROLLED YOUTH (Group 4):\n\n* Are the biological parent or legal guardian of an enrolled adolescent (who is a healthy volunteer or has MDD) participant; Parents of those with s-MDD are historical only; none enrolled after Dec 2021.\n* Those of all ages are eligible if they are a parent of a currently enrolled participant\n\nEXCLUSION CRITERIA: (All patients)\n\n-Exclusion Criteria for MDD patients (Group 1)\n\n* Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, current Anorexia Nervosa or other severe Eating Disorder.\n* Intellectual disability (clinically identified or IQ \\\u003C 70)\n* For subjects with major depression or sub-threshold major depressive episode: Symptoms of depression are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition by self and parent report.\n* Meets DSM-5 criteria for alcohol or substance use disorder (excluding tobacco and nicotine use) within the last three months. This is determined solely by clinical interview of child and parent (e.g., KSADS).\n* Current active suicidal ideation (i.e., presence of intent for engaging in suicidal behaviors).\n\nYouths with passive suicidal ideation and\u002For past active suicidal ideation are still eligible.\n\n* Participants with repeated self-harm occurring in the context of inter-personal conflict.\n\n  -Exclusion criteria for youths meeting modified DSM criteria for Subthreshold Depression (Group 2) (this cohort is historical only; previously n=200 to be enrolled; ceased enrolling this population with Amendment J (2022); none enrolled after Dec 2021):\n* Intellectual disability (clinically identified or IQ \\\u003C 70).\n* Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.\n* Past or current diagnosis of a manic or hypomanic episode, major depression), schizophrenia, schizophreniform disorder, schizoaffective illness, Tourette Disorder, or Autism Spectrum Disorder, Anorexia Nervosa or other severe Eating Disorder.\n* Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report.\n* NIMH IRP Employees\u002Fstaff and immediate family members will be excluded from the study per NIMH policy.\n\n  -Healthy volunteer youths and adults exclusion criteria:\n* Intellectual disability (clinically identified or IQ \\\u003C 70).\n* Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.\n* Past or current diagnosis of any mood disorder (manic or hypomanic episode, major depression), anxiety disorder (except specific phobia), Obsessive Compulsive Disorder (OCD), Post-Traumatic Stress Disorders (PTSD), Conduct Disorder, schizophrenia, schizophreniform disorder, schizoaffective illness, Tourette Disorder, or Autism Spectrum Disorder.\n* Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report; for adults, past history of substance dependency or substance abuse within the last three months by self-report.\n\nParents of enrolled participants (group 3) exclusion criteria:\n\n--Parents who are unable to understand or read English well enough to complete the study interview and tests.","11 Years","25 Years",{"count":138,"type":22},"This research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. The study will also compare teenagers with depression to those without mental health diagnoses.\n\nThis outpatient study is recruiting participants ages 11-17 who are depressed. They must have a pediatrician or other medical provider, be medically healthy, and able to perform research tasks. They may not currently be hospitalized, psychotic or actively suicidal. Teenagers with depression are eligible even if they are taking medication.\n\nThe study begins with an evaluation that includes clinical assessment, interviews, and questionnaires.\n\n* Visits may include paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and brain imaging. If eligible, study participants may return several times a year for up to two years. This part of the study does not involve treatment.\n* Participants may be eligible for outpatient treatment for up to 25 weeks. This includes evidenced-based \"talk\" therapy. Participants may choose either Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy (CBT). If indicated, participants may opt to receive standard medication treatments along with psychotherapy. Research includes computer tasks and brain imaging.\n\nAll clinical evaluations, research tasks and visits are free of cost. Participants are compensated for research activities. Parents and teenager must agree to the teenager s participation in research.\n\nThe study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed by NIMH....",[351],[371,372,373,374,375,147],"Cognitive Behavior Therapy","Mood Disorder","Biomarkers","Mechanism","Major Depressive Disorder (MDD)",{"date":191,"type":41},{"date":378,"type":41},"2017-12-28",{"date":380,"type":22},"2027-07-01",{"name":47,"class":48},3,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":389,"targetDuration":4,"studyType":111,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":49},"100153235","development-of-magnetic-resonance-spectroscopic-imaging-techniques-for-imaging-metabolites-in-human-brain-and-muscle-100153235","NCT01266577","Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle","* INCLUSION CRITERIA:\n* 18-65 years of age\n* able to give written informed consent\n* healthy based on medical history and physical exam\n* enrolled in Protocol 01-M-0254 or Protocol 17-M-0181\n\nEXCLUSION CRITERIA:\n\n* Any current Axis 1 diagnosis\n* Clinically significant laboratory abnormalities\n* Positive HIV test\n* Metallic foreign bodies that would be affected by the magnetic resonance imaging (MRI) magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.\n* History of neurological illness or injury with the potential to affect study data interpretation, such as multiple sclerosis, Parkinson s disease, seizure disorder or traumatic brain injury\n* Inability to lie flat on camera bed for about two and a half hours\n* Pregnant or breastfeeding\n* Current substance use disorder based on DSM-5\n* NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.",{"count":159,"type":22},[324],"Background:\n\n\\- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.\n\nObjectives:\n\n\\- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.\n\nEligibility:\n\n\\- Healthy individuals between 18 and 65 years of age.\n\nDesign:\n\n* This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center.\n* Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing.\n* During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment....",[393,89],"Brain Mapping",[395,396,146,397,398],"Brain Metabolism","Neurochemistry","Mental Illness","Magnetic Resonance Spectroscopy",{"date":191,"type":41},{"date":401,"type":41},"2011-01-27",{"date":403,"type":22},"2026-10-23",{"name":47,"class":48},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":106,"sex":17,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":415,"conditions":416,"keywords":421,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":4,"leadSponsor":430,"locationsCount":49},"100078073","the-neurodevelopmental-and-behavioral-phenotyping-screening-protocol-100078073","NCT00271622","The Neurodevelopmental and Behavioral Phenotyping Screening Protocol","Neurodevelopmental and Behavioral Phenotyping Screening Protocol","* INCLUSION CRITERIA:\n* Subjects must be at least 6 weeks of age.\n* Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents\u002Fguardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.\n* Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).\n\nEXCLUSION CRITERIA:\n\n-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians\u002Fcaretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.","6 Weeks",{"count":414,"type":22},5000,"The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH....",[417,418,419,420],"Neurologic Disorders","Autism","Neurodegenerative Disease","Neurobehavioral Manifestation",[422,68,423,424,425,426,89,169],"Developmental Delay","Pervasive Developmental Disorder","Early Development","Healthy Control Subjects","Autism Spectrum Disorders",{"date":191,"type":41},{"date":429,"type":41},"2006-02-27",{"name":47,"class":48},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":259,"enrollmentInfo":437,"targetDuration":4,"studyType":111,"phases":438,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":49},"100642123","phase-1-evaluation-of-11cztp-1-to-image-pde4b-100642123","NCT07625345","Evaluation of [11C]ZTP-1 to Image PDE4B","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n* Aged 18 years or older.\n* Must have undergone a screening assessment under protocol 01M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or protocol 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies.\"\n* Be healthy based on medical history, physical examination, and laboratory testing.\n* Able to provide informed consent.\n* Willingness to complete all study procedures including MRI tests.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* History of neurologic illness or injury with the potential to affect study data interpretation.\n* History of seizures, other than in childhood and related to fever.\n* Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n* HIV infection.\n* Pregnancy or breastfeeding.\n* Must not have substance use disorder or alcohol use disorder.\n* Unable to travel to the NIH.\n* Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors (e.g. apremilast, roflumilast, nerandomilast, crisborole).\n* Taking CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, erythromycin, ritonavir); CYP3A4 inducers (e.g. phenobarbital St. John's Wort, rifampicin) or oral contraceptives containing gestodene and ethinyl estradiol.\n\nEXCLUSION OF CHILDREN:\n\nInclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.\n\nEXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant. The test must be negative in order to continue on the study. In addition to completing a negative urine pregnancy test, on the day of PET scanning prior to PET scan procedures, participants of childbearing potential will undergo a clinical pregnancy screening interview with a licensed independent practitioner to confirm lack of pregnancy.\n\nEXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE:\n\nPersons with HIV infection are excluded because HIV infection itself may change cAMP signaling.",{"count":183,"type":22},[113],"Background:\n\nPDE4B is a protein in cells that helps turn off certain chemical signals after they ve done their job. It controls inflammation, immune responses, and some brain signaling. Measuring PDE4B levels in the body can help doctors manage a disease or know if a treatment is working. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them measure PDE4B in people more effectively.\n\nObjective:\n\nTo test a new tracer (\\[11C\\]ZTP-1) during imaging scans of the brain and body in healthy people.\n\nEligibility:\n\nHealthy people aged 18 and older. They must have been screened under protocols 01M-0254 or 17M0181.\n\nDesign:\n\nParticipants will have either 1 or 2 clinic visits.\n\nDuring their first visit, all participants will have a positron emission tomography (PET)\u002Fcomputed tomography (CT) scan. Prior to the scan, they will have blood and urine tests and a test of their heart function. The study tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.\n\nSome participants will have a PET\u002FCT scan of their whole body. They will need only 1 visit. The visit will last up to about 8 hours.\n\nSome participants will have a PET\u002FCT scan of only their brain. They will also have a magnetic resonance imaging (MRI) scan of the brain. They may need to return for a second visit for the MRI scan.\n\nParticipants will receive a follow-up call to check on their well-being after their PET\u002FCT scans.",[118],[121,442],"11C-ZTP-1",{"date":444,"type":41},"2026-08-17",{"date":446,"type":41},"2026-07-01",{"date":448,"type":22},"2030-10-03",{"name":47,"class":48},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":456,"maxAge":233,"enrollmentInfo":457,"targetDuration":4,"studyType":111,"phases":458,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":49},"100595083","phase-1-acute-effects-of-alcohol-on-pet-imaging-of-phosphodiesterase-4b-pde4b-100595083","NCT07027839","Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Be enrolled in protocol 14-AA-0181, NIAAA Natural History Protocol.\n2. Age 21 - 70 years.\n3. Willingness to complete the study including MRI tests.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of AUD or SUD. Participants may currently use cannabis recreationally but cannot meet criteria for cannabis use disorder, or present for study visits with positive urine drug screen for THC.\n2. Current non-drinkers (alcohol-naive individuals or no use of alcohol in the past year), or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime.\n3. Current or prior history of alcohol-induced flushing reactions, including rapid reddening of the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks.\n4. Clinically significant abnormalities on EKG or laboratory tests: CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen), liver function tests (GGT, AST, ALT, bilirubin).\n5. Participants who have taken an antipsychotic or antidepressant medication within two weeks prior to the PET scan #1, with longer washout times of 1 month for antidepressants with longer half-lives such as fluoxetine. In addition, they will be withdrawn if they begin these medications during the two PET scans.\n6. Medication exclusion for alcohol:\n\n6a. Use of prescription or OTC medication known to interact with alcohol 2 weeks prior to screening or screening update visit. These include but may not be limited to: isosorbide; nitroglycerine; benzodiazepines; warfarin; anti-depressants such as amitriptyline, clomipramine and nefazodone; anti-diabetes medications such as glyburide, metformin and tolbutamide; H2-antagonists for heartburn such as famotidine, cimetidine and ranitidine; muscle relaxants; anti-epileptics including phenytoin and phenobarbital; codeine and opioid analgesics including Darvocet, Percocet and hydrocodone.\n\n6b. Regular (more than once a week) or prescribed use of antihistamines, pain medicines, and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib, and naproxen, and unable to refrain from these medications for 48 hours prior to study visits\n\n6c. Use of medications known to inhibit or induce enzymes that metabolize alcohol for 4 weeks prior to screening or screening update visit. These include chlorzoxazone, isoniazid, metronidazole, and disulfiram.\n\n7\\) HIV infection.\n\n8\\) Pregnancy or breast feeding.\n\n9\\) Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n\n10\\) Have an inability to lie flat and\u002For lie still on the camera bed for two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n\n11\\) Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye","21 Years",{"count":279,"type":22},[113],"Background:\n\nPhosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several mental health disorders. Researchers want to know if drinking alcohol increases the binding of a radioactive tracer to PDE4B in the brain because of increased activity and\u002For amount of the protein. This knowledge may help create new ways to treat people with alcohol use disorder (AUD).\n\nObjective:\n\nTo learn if alcohol increases PDE4B activity in the brain.\n\nEligibility:\n\nHealthy people aged 21 to 70 years who drink socially but do not have AUD. They must be enrolled in protocol 14-AA-0181\"NIAAA Natural History Protocol\".\n\nDesign:\n\nParticipants will have up to 4 clinic visits with up to 3 imaging scans of the brain; these will include 1 or 2 positron emission tomography (PET) scans and 1 magnetic resonance imaging (MRI) scan.\n\nThe first PET scan will be a baseline. Participants will receive a radioactive tracer through a tube inserted into a vein. A second tube will be inserted so that blood can be drawn during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. This visit will take about 6 hours.\n\nFor the next PET scan, participants will receive alcohol (ethanol) through a tube in a vein until they have a blood alcohol concentration that is equal to the legal driving limit. This is the same as 4 or 5 drinks for most people. After the scan, participants must remain at the clinic for a few hours until their blood alcohol drops. This visit will take 14 to 16 hours.\n\nThe MRI scan of the brain will take up to 2 hours in a separate clinic visit.",[283],[121,285,286],{"date":444,"type":41},{"date":464,"type":41},"2025-12-11",{"date":251,"type":22},{"name":47,"class":48},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":233,"enrollmentInfo":473,"targetDuration":4,"studyType":111,"phases":475,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":49},"100493325","phase-1-18fpf-06445974-to-image-pde4b-in-major-depressive-disorder-using-pet-100493325","NCT05703685","[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible for this study, MDD participants must meet all of the following criteria:\n\n* 18 to 70 years of age.\n* Female participants of childbearing potential must be using a medically acceptable means of contraception.\n* Be in good general health as evidenced by medical history and physical examination. Stable medical conditions as assessed by their primary care provider (PCP) and\u002For in-house clinician are permitted to join the study.\n* Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* All participants must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .\n* Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).\n* Participants must have an initial score on the MADRS \\>= 18 or HAM-D \\>= 15 within one week of study entry.\n* Participants must be experiencing an MDE lasting at least four weeks.\n* All MDD participants must have a PCP or psychiatrist in the community.\n* Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:\n\n* Aged 18 to 70 years old.\n* Female participants of childbearing potential must be using a medically acceptable means of contraception.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n* Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with MDD who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n* Participants must be free of all prohibited medications for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified\n\n(including herbal products), and sedatives\u002Fhypnotics.\n\n* Current psychotic features, a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.\n* Participants with a history of psychiatric inpatient hospitalization within the past year.\n* Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n* Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n* Participants with suicidal ideation within the past 6 months.\n* Participants with suicidal behavior within the past 12 months.\n* Participants who have a history of aggressive behavior towards others.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* HIV infection.\n* Pregnancy.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nHealthy controls who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics.\n* Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n* Participants who have a history of major depressive disorder.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* HIV infection.\n* Pregnancy.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Use of cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin).\n* Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigator.",{"count":474,"type":22},108,[113],"Background:\n\nMajor depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains.\n\nPrimary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \\[18F\\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast.\n\nEligibility:\n\nPeople aged 18-70 years with MDD. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits.\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics.\n\nParticipants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder.\n\nParticipants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\\[18F\\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break.\n\nParticipants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan.\n\nSome participants may return for a second PET scan; have a lung scan or receive apremilast.\n\nhttps:\u002F\u002Fnimhcontent.nimh.nih.gov\u002Fstart\u002Fsurveys\u002F?s=KE88DXXPLDFHHTF8",[351],[121,351,479],"Phosphodiesterase-4",{"date":444,"type":41},{"date":482,"type":41},"2023-06-22",{"date":484,"type":22},"2029-04-11",{"name":47,"class":48},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":111,"phases":496,"briefSummary":497,"conditions":498,"keywords":503,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":510,"locationsCount":49},"100392965","phase-1-pet-imaging-of-cyclooxygenases-in-neurodegenerative-brain-disease-100392965","NCT04396873","PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Agree to adhere to the lifestyle considerations.\n\nHealthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception\n3. Able provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL\n2. Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.\n4. Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and\u002For caregiver during the screening visit.\n9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past.\n11. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n12. Pregnancy\n13. HIV infection\n14. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.","99 Years",{"count":495,"type":22},184,[113],"Background:\n\nAbout 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation.\n\nObjective:\n\nTo learn whether COX-1 and\u002For COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.\n\nEligibility:\n\nAdults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured.\n\nParticipants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs.\n\nParticipants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan.\n\nParticipants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.",[499,500,501,502,117],"Parkinson's Disease","Dementia","Alzheimer's Disease","ALS",[121,504,242,500,353,502,505],"PD","MCI",{"date":444,"type":41},{"date":508,"type":41},"2021-08-17",{"date":448,"type":22},{"name":47,"class":48},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":233,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":49},"100309156","recruitment-and-characterization-of-healthy-research-volunteers-for-nimh-intramural-studies-100309156","NCT03304665","Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies","* INCLUSION CRITERIA:\n* 18 - 70 years of age.\n* Able to read, speak, and understand English.\n* Able to provide informed consent.\n* In current good general health.\n\nEXCLUSION CRITERIA:\n\n* Have a history of significant or unstable medical or mental health condition requiring treatment, such as heart or lung disease, depression or psychosis.\n* Endorse current self-injury, suicidal thoughts or behavior.\n* Have current illicit drug use by history or urine drug screen.\n* Are found to have an abnormal physical exam or laboratory result that may require treatment or further evaluation.\n* Less than an 8th grade education.\n* Pregnancy.\n* Positive HIV test as HIV positivity has been associated with neurological changes.\n\nOptional Brain MRI scan exclusion criteria:\n\n* Metal in body which would make having an MRI scan unsafe.\n* Being uncomfortable in small, closed spaces such as the MRI machine.\n* Inability to lie comfortably on back for at least 45 minutes.\n* Pregnancy.\n\nOptional MEG recording exclusion criteria:\n\n-Metal in body which would cause artifacts on MEG recordings.",{"count":518,"type":22},2000,"Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. Develop a normative set of structural and functional brain MRI scans that are linked to healthy research volunteer characteristics. Maximize scientific impact of data from volunteers by broadly sharing with other researchers.\n\nStudy Population: Adult males and females in general good health who are 18 years of age and older.\n\nDesign: Adult individuals who are interested in participating in NIMH IRP clinical studies as a healthy research volunteer can directly visit or be directed to visit the study website where they will first consent electronically and then complete a set of online self-report measures. Items may include: demographic information, mental health symptoms, disability status, substance use patterns, handedness and clinical\u002Ffamily history. Individuals who are flagged based on predetermined responses to survey items will be further screened by a member of the study clinical team. If found to be ineligible for the study because of a clinically significant or unstable medical or mental health condition, these individuals will be referred back to the community and\u002For given information about NIMH clinical studies for which they may be eligible. Respondents with no flags or who pass through additional screening will be scheduled for an in-person assessment. During the outpatient appointment and after in-person informed consent, participants will receive a brief clinical interview to screen for current medical and mental conditions, and risk for self-harm. They will complete assessments of psychological, emotional, physiologic, biological and cognitive functioning. Participants will undergo a physical exam and be asked to provide blood and urine samples for routine clinical labs. Participants can separately consent for an optional baseline brain magnetic resonance imaging (MRI) scan and an optional magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that if enrolled in the study, their de-identified data will be broadly and publicly shared through NIH-approved data repositories. Participants in this recruitment and characterization study will then be placed on a list of healthy research volunteers from which other NIMH IRP studies may recruit according to the inclusion and exclusion criteria in their respective IRB-approved protocols.\n\nOutcome Measures: Outcome measures may include demographic data, mental and medical history and symptoms, results of psychological, emotional, physiologic, biological, and cognitive testing, physical exam and MRI findings....",[89],[89,522,523],"Mental Health","Common Data Elements",{"date":444,"type":41},{"date":526,"type":41},"2017-11-01",{"date":528,"type":22},"2028-03-01",{"name":47,"class":48},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":536,"targetDuration":4,"studyType":111,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":49},"100290790","phase-1-neuropharmacologic-imaging-and-biomarker-assessments-of-response-to-acute-and-repeated-dosed-ketamine-infusions-in-major-depressive-disorder-100290790","NCT03065335","Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder","* INCLUSION CRITERIA:\n\nInclusion Criteria: All Subjects (Main Study)\n\n1. 18 to 65 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under either protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\" or protocol 17-M-0181 (\"Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies\").\n4. Agree to be hospitalized\n\nAdditional Inclusion Criteria: Patients with MDD (Main Study)\n\n1. At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.\n2. At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS \\>= 20 and YMRS of \\\u003C 12.\n3. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.\n\nKetamine Metabolites Substudy Inclusion Criteria: Healthy Volunteers\n\n1. 18 to 65 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under either protocol 01-M-0254 \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\") or 17-M-0181 (\"Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies\").\n4. Agree to be hospitalized.\n\nEXCLUSION CRITERIA:\n\nAdditional Exclusion Criteria: Patients with MDD (Main Study)\n\n1. Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses.\n2. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n3. Subjects with a history of DSM-IV or DSM-5 drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) urine test at screening.\n4. Treatment with a reversible MAOI within two weeks prior to Phase II.\n5. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n\nExclusion Criteria: All Subjects (Main Study)\n\n1. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to MRI and infusion of ketamine.\n2. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n3. Clinically significant abnormal laboratory tests.\n4. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures.\n5. Treatment with any other concomitant medication 14 days prior to Phase II. An exception of this would be necessary for those who are taking Fluoxetine or Aripiprazole. Prior to Phase II, treatment with Fluoxetine must be discontinued for at least 5 weeks and treatment with Aripiprazole must be discontinued for at least 3 weeks.\n6. Any use of opioid medication in the past 3 months\n7. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing imaging component of the study only).\n8. Presence of any medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n9. Subjects who have hearing loss that has been clinically evaluated and diagnosed\n10. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only).\n11. Positive HIV test\n12. Weight \\> 119 kg\n13. \\[for participants undergoing NPU Threat Test with Auditory Startle\\] Known history of hearing loss\n\nAdditional Exclusion Criteria: Healthy Volunteers (Main Study)\n\n1\\. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).\n\nKetamine Metabolites Substudy Exclusion Criteria: Healthy Volunteers\n\n1. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).\n2. Current (within the past 3 months) or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine)\n3. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the 4-days of the study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to infusion of ketamine.\n4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n5. Clinically significant abnormal laboratory tests.\n6. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.\n7. Treatment with any other concomitant medication.\n8. Any use of opioid medication in the past 3 months\n9. Positive HIV test\n10. Weight \\> 119 kg\n11. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing neuroimaging component of the study only).\n12. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects requiring clinical MRI scans for safety and\u002For structural MRI scans for MEG coregistration).",{"count":537,"type":22},150,[113],"Background:\n\nMost medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.\n\nObjective:\n\nMain Study: To study the effects of ketamine in treating depression.\n\nKetamine Metabolites Substudy: To study how ketamine effects brain chemistry.\n\nTo study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.\n\nEligibility:\n\nMain Study: People ages 18-65 with major depressive disorder and healthy volunteers\n\nKetamine Metabolites Substudy: Healthy volunteers ages 18-65\n\nDesign:\n\nMain Study:\n\nParticipants will be screened in another study, with:\n\n* Medical and psychiatric history\n* Psychiatric and physical exam\n* Blood, urine, and heart tests\n\nParticipants will be inpatients at NIH for 4 phases totaling 14-20 weeks.\n\nPhase I (2-7 weeks):\n\n* Gradually stop current medications\n* MRI: Participants lie and perform tasks in a machine that takes pictures of the body.\n* Mood and thinking tests\n* Blood and urine tests\n* Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.\n* Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.\n* Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.\n\nPhase I tests are repeated in Phases II and III and in the final visit.\n\nPhase II (4-5 weeks):\n\n* 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.\n\nPhase III (optional):\n\n* 8 infusions of ketamine over 4 weeks\n\nPhase IV (optional):\n\n* Symptoms monitoring for 4 weeks\n* Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.\n\nKetamine Metabolites Substudy:\n\nParticipants will be screened in another study, with:\n\n* Medical and psychiatric history\n* Psychiatric and physical exam\n* Blood, urine, and heart tests\n\nParticipants will be inpatients at NIH for 4 days.\n\nStudy Procedures:\n\nMood and thinking tests\n\nBlood and urine tests\n\n1 infusion of ketamine\n\nSpinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry",[89,541,351],"Major Depressive Disorder",[146,333,541,543,544],"Ketamine","Neuropharmacology",{"date":444,"type":41},{"date":547,"type":41},"2017-05-25",{"date":549,"type":22},"2028-01-01",{"name":47,"class":48},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":106,"sex":17,"minAge":135,"maxAge":233,"enrollmentInfo":558,"targetDuration":4,"studyType":111,"phases":560,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":49},"100250835","phase-2-neurobiology-of-suicide-100250835","NCT02543983","Neurobiology of Suicide","The Neurobiology of Suicide","* INCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score \\>= 90% on the Baseline consent quiz\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n4. Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Patients must have completed Study Phase I as a participant in Group 1 or 5\n2. Participants must verify understanding of the protocol by a score \\>= 80% on the Ketamine Response consent quiz.\n3. Patients in Group 1 or 5 must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase.\n\n   * MADRS score of over 10 (10 used as an outcome measure for remission)126\n   * OR HAMA score of over 7 (7 used as an outcome measure for remission)127\n   * OR SSI score of 2 or more (indicates any residual suicidal thoughts)\n4. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase II.\n\nPhase III: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests\u002Fexaminations.\n2. Current drug or alcohol dependence\n3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.\n4. Pregnant or nursing individuals or those who plan to become pregnant.\n5. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.\n6. Clinically significant abnormal laboratory tests.\n7. Positive HIV test\n8. Participants who, in the investigator s judgment, pose a current homicidal risk or pose suicide risk that cannot be managed in a secure, voluntary inpatient setting.\n9. Non-English speakers\n10. Additional Criteria for Group 1 (Active Crisis): For participants who still experience the effects of their suicide attempt, i.e. someone who overdosed is significantly drowsy or confused, the consenting process will occur after the patient has improved from the effects. If there is a concern around a participant's capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is\n\nmonitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. Current or past Axis I diagnosis\n2. Presence of medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or \"substance abuse disorder\" per DSM-V).\n4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.\n5. Pregnant or nursing individuals or those who plan to become pregnant.\n6. No lifetime suicide attempts or ideations\n7. Non-English speakers\n8. Positive HIV test\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II.\n2. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase II.\n3. Subjects with one or more seizures without a clear and resolved etiology\n4. Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.\n5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n6. Pregnant or nursing individuals or those who plan to become pregnant.\n7. A medical finding or condition that in the clinical judgement of the investigator increases the risk of adverse effects from the ketamine administration (for example: findings suggesting difficulties with kidney or cardiac function that may be contraindications for an experimental intervention).\n\nPhase III: Repeated Administration (Group 1) and Group 5 (Suicide Ideators)\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III.\n3. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase III.\n4. Subjects with one or more seizures without a clear and resolved etiology\n5. Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.\n6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n7. Pregnant or nursing individuals or those who plan to become pregnant.\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures",{"count":559,"type":22},325,[561],"PHASE2","Background:\n\nThere are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.\n\nObjective:\n\nTo understand what happens in the brain when someone has thought about or attempted suicide.\n\nEligibility:\n\nGroup 1: Adults ages 18 70 who have thought about or attempted suicide recently\n\nGroup 2: Adults ages 18 70 who have thought about or attempted suicide in the past\n\nGroup 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide\n\nGroup 4: Healthy volunteers the same ages.\n\nDesign:\n\nParticipants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.\n\nPhase 1: 1 week in hospital. Participants will have:\n\nPhysical exam.\n\nQuestions about thoughts and feelings.\n\nThinking and memory tests and simple tasks.\n\nBlood and urine tests.\n\nTwo MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.\n\nSleep test. Disks and bands will be placed on the body to monitor it during sleep.\n\nMagnetic detectors on their head while they perform tasks.\n\nA wrist monitor for activity and sleep.\n\nLumbar puncture (optional). A needle will collect fluid from the back.\n\nShock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.\n\nPhase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.\n\nPhase 3: up to 4 more ketamine doses over 2 weeks.\n\nParticipants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.\n\n...",[564,351],"Healthy Volunteers",[566,567,543,541,373],"Neurobiology","Suicide",{"date":444,"type":41},{"date":570,"type":41},"2015-12-01",{"date":572,"type":22},"2030-07-21",{"name":47,"class":48},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":106,"sex":17,"minAge":581,"maxAge":493,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":584,"conditions":585,"keywords":589,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":4,"leadSponsor":595,"locationsCount":49},"100192257","studying-childhood-onset-behavioral-psychiatric-and-developmental-disorders-100192257","NCT01778504","Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders","Diagnosis of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders","* INCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n1. Are 30 days to 99 years old.\n2. Either:\n\n   -Have a diagnosed neuropsychiatric disorder or neurodevelopmental disability or related symptoms without a formal diagnosis\n\n   OR\n\n   -Are a biological relative of someone who meets the criteria above.\n3. Have the ability to understand and sign an informed consent on behalf of themselves, or have a legal guardian (or designated DPA).\n4. Are under the care of a primary physician.\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n1. Are unwilling or unable to be evaluated and followed as clinically indicated. Examples might include children with severe behavioral problems who refuse physical examination.\n2. The participant does not have a primary healthcare provider.","30 Days",{"count":583,"type":22},1000,"Background:\n\n\\- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders.\n\nObjectives:\n\n\\- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders.\n\nEligibility:\n\n* Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems.\n* Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts\u002Funcles, cousins, and children.\n\nDesign:\n\n\\- Participants will be screened with a medical history and physical exam. They may have a psychiatric history with tests of thinking, judgment, and behavior....",[586,167,587,588],"Neuropsychiatric Disorder","Neurodevelopmental Disorder","Sleep",[590,397,418,422,591,147],"Natural History Study","Genetic Disorder",{"date":444,"type":41},{"date":594,"type":41},"2012-12-27",{"name":47,"class":48},""]