[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,583,0,25,[9,42,76,101,126,151,179,205,224,251,277,313,336,355,378,400,425,449,475,505,532,566,585,617,636],{"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":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100556513","cognitive-training-as-an-adjunct-to-ketamine-in-real-world-clinics-100556513",false,"NCT06526078","Cognitive Training as an Adjunct to Ketamine in Real-world Clinics","A Brief Automated Neurocognitive Training to Enhance the Real-World Impact of Ketamine's Rapid Antidepressant Effect","Inclusion Criteria:\n\n1. be between the ages of 18 and 80 years\n2. score ≥20 on the Montgomery-Asberg Depression Rating Scale (MADRS)\n3. per SCID-5-RV interview, meet DSM-5 diagnostic criteria for at least one of the following: Major Depressive Disorder, Bipolar Disorder (I or II), Persistent Depressive Disorder, or Other Specified Depressive or Bipolar Disorder\n4. exhibit treatment resistance, defined as: (a) failure to respond to ≥1 adequate trials of an evidence-based treatment for mood disorder \\[per the Antidepressant Treatment History Form-Short Form Modified Score Sheet (ATHF-SF-Modified)\\] and\u002For (b) failure to respond to ≥1 adequate mood stabilizer or other evidence-based treatment trials (for bipolar depression patients) and\u002For (c) a history of intolerance during attempted trials of evidence-based treatments for mood disorders and\u002For (d) failure to respond to ≥1 prior treatment trials (e.g., medication, psychotherapy) for Post Traumatic Stress Disorder (PTSD)\n5. be eligible and clinically enrolled for an upcoming ketamine or esketamine induction series at one of our study clinics according to that clinic's standard intake procedures\n6. agree to maintain a stable schedule of concomitant psychiatric medications throughout the ketamine induction phase (minor adjustments to PRN meds and timing of meds are allowable), and for 4 weeks post-induction phase\n7. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document\n8. be willing and able to provide names and contact information for at least 1 additional emergency contact in the patient's proximal geographic area (in addition to the ketamine treatment team at the enrolling site)\n\nExclusion Criteria:\n\n1. Presence of current\u002Facute psychosis, mania, or dementia, or a diagnosis of developmental disorder with significant language and\u002For intellectual impairment (e.g., autism spectrum disorder)\n2. Current\u002Facute suicide risk with intent to act, defined as CSSRS past-week ideation score ≥ 4 among outpatients; patients engaged in residential or inpatient care at the time of enrollment need not meet this CSSRS score criterion, as their current\u002Facute suicide risk is extremely low by virtue of the residential\u002Finpatient, round-the-clock care they are already receiving at time of enrollment\n3. Concern for dementia or significant cognitive decline, per interviewer observations and impressions during screening assessments\n4. Current pregnancy\n5. English reading level \\\u003C5th grade as per patient self-report Rationale: to ensure adequate reading comprehension for verbal ASAT\u002Fsham stimuli which are presented in English","ALL","18 Years","80 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25],"NA","In a sample of patients already receiving ketamine (or esketamine) treatment as part of their clinical care, this project seeks to test whether we can enhance and\u002For extend (es)ketamine's rapid effects by introducing helpful information delivered by a computer-based cognitive training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.",[28],"Depression","RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-19","ACTUAL",{"date":35,"type":33},"2024-11-12",{"date":37,"type":22},"2029-05-31",{"name":39,"class":40},"University of Pittsburgh","OTHER",3,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100556310","accelerated-intermittent-theta-burst-in-treatment-naive-adolescents-100556310","NCT06523439","Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents","Investigating a Truncated Version of paiTBS in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial","paiTBS-KID","Inclusion Criteria:\n\n1. Male or Female, between the ages of 13 and 20 at the time of screening.\n2. Able to read, understand, and provide written, dated assent and\u002For consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.\n3. Diagnosed with Major Depressive Disorder (MDD) with a current Major Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).\n4. No prior major depressive episodes (MDEs) as determined by MINI-KID\n5. CDRS-R score of ≥40 at screening (Visit 1).\n6. Treatment-naive as determined by the ATHF (no adequate antidepressant trials prior to screening defined as fewer than 12 weeks of antidepressant medication in the past 2 years and fewer than 10 psychotherapy sessions for depression in the past year; willingness to taper medications and stop psychotherapy if recently started and within the window defined above.)\n7. TMS naive.\n8. Access to ongoing psychiatric care before and after completion of the study.\n9. In good general health, as evidenced by medical history.\n10. Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. High-risk for suicide or active suicidal ideation as determined by clinical interview\n3. The presence or diagnosis of prominent anxiety disorder, or dysthymia (\\>4 on SAPAS; \\>16 on GAD-7)\n4. Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)\n5. Current mania or psychosis\n6. Bipolar Affective Disorder and\u002For primary psychotic disorders.\n7. Autism Spectrum disorder or Intellectual Disability\n8. A diagnosis of obsessive-compulsive disorder (OCD)\n9. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.\n10. Urine screening test positive for illicit substances.\n11. Any history of ECT (greater than 8 sessions) without meeting responder criteria\n12. Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).\n13. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure\u002Fepilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.\n14. Untreated or insufficiently treated endocrine disorder.\n15. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)\n16. Contraindications to MRI (ferromagnetic metal in their body).\n17. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.\n18. Depth-adjusted aiTBS treatment dose \\> 65% maximum stimulator output (MSO)\n19. Treatment with another investigational drug or other intervention within the study period.\n20. Any other condition deemed by the PI to interfere with the study or increase risk to the participant.","13 Years","20 Years",{"count":53,"type":22},40,[25],"This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS)-is effective as a first-line therapy in treating adolescents aged 13-20 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial.\n\nThe main questions this trial aims to answer are:\n\n* Does aiTBS relieve symptoms of depression as a first-line therapy in adolescents?\n* Is aiTBS a feasible option as a first-line treatment for adolescent depression?\n\nResearchers will measure the depression symptoms in adolescent participants before and after aiTBS. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment.\n\nAdolescent participants will:\n\n* Remain antidepressant-free throughout the study period of 6-7 weeks.\n* Receive an fMRI of their head for precision targeting\n* Receive 5 days of aiTBS",[57,58,28,59],"Major Depressive Disorder","Depression in Adolescence","Major Depressive Episode",[61,62,63,64,65,66,67],"Stanford Accelerated Intelligent Neuromodulation Therapy","SAINT","Transcranial Magnetic Stimulation","Accelerated Theta Burst Stimulation","Accelerated Intermittent Theta Burst Stimulation","TMS","TMS in Adolescents",{"date":32,"type":33},{"date":70,"type":33},"2025-04-01",{"date":72,"type":22},"2027-12",{"name":74,"class":40},"University of Texas at Austin",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100492933","compassion-for-psychiatric-disorders-and-self-stigma-100492933","NCT05698589","COMpassion for Psychiatric Disorders And Self-Stigma","Compassion Focused Therapy (CFT) for the Reduction of the Internalized Stigma of Mental Disorders: a Multi-center, Prospective, Randomized, Controlled Study","COMPASS","Inclusion Criteria:\n\n1. Patient ≥18 years of age\n2. Patient informed of the results of the preliminary medical examination\n3. Patient affiliated to a social health insurance plan (beneficiary or beneficiary's family)\n4. Patient with one or several diagnoses of chronic psychiatric disorder (schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depression, borderline personality disorder) or a neurodevelopmental disorder (autism spectrum disorder) treated as an outpatient or in a day hospital\n5. CGI-Severity score\\\u003C6 assessed by the psychiatrist (Berk et al., 2008) ISMI score indicating moderate to high self-stigma (\\>2.5; Lysaker et al., 2007)\n\n   Exclusion criteria:\n6. Patient in an exclusion period determined by a previous or ongoing study\n7. Patient participating in an interventional study involving psychotherapy or an experimental drug\n8. Patient in acute episode of their disorder according to the CGI Severity score\n9. Patient in a medical emergency or immediate life-threatening situation\n10. Patients with an intellectual disability (IQ\\\u003C70) estimated via the fNART (Mackinnon \\& Mulligan, 2005)\n\n12\\. Legal issues: care under constraint or patient deprived of freedom because of a judicial measure 13. Patient who does not speak and read French sufficiently",{"count":85,"type":22},336,[25],"People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma.\n\nIn this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.",[89,90,28,91,92],"Bipolar Disorder","Schizophrenia","Borderline Personality Disorder","Autism Spectrum Disorder",{"date":32,"type":33},{"date":95,"type":33},"2023-04-03",{"date":97,"type":22},"2028-03-01",{"name":99,"class":40},"University Hospital, Strasbourg, France",7,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":75},"100478220","phase-2-a-digital-intervention-for-post-stroke-depression-and-executive-dysfunction-100478220","NCT05507138","A Digital Intervention for Post-Stroke Depression and Executive Dysfunction","Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke","Inclusion Criteria:\n\n* first-time stroke that occurred 6 months or more prior to study initiation\n* executive dysfunction as defined by a score of less than 1 standard deviation below age-adjusted normative score on at least one test of executive function in the screening assessment\n* diagnosis of Major Depressive Episode assessed by the Structured Clinical Interview for the DSM-5 (SCID).\n* at least moderate depressive symptoms as defined by Montgomery Asberg Depression Rating Scale ≥ 18\n* motor function sufficient to operate an iPad and use a pen, based on self-report and observation\n* if treated with an antidepressant medication, must be on a stable dose for a minimum of 8 weeks at the time of study enrollment.\n* able to adhere to all testing and study requirements and willingness to participate in the full study duration\n\nExclusion Criteria:\n\n* receptive aphasia as determined by a score of 2 or 3 on the NIH Stroke Scale \\[NIHSS\\] item 9 (\"Best Language\")\n* dysarthria that makes speech unintelligible (score of 2 on NIHSS item #10)\n* severe visual impairment or hemispatial neglect (score of 3 on NIHSS item #3 or score of 2 on NIHSS item #11)\n* patient already enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is already enrolled in psychotherapy, this will not be grounds for exclusion)\n* non-fluency in English\n* presence of or history of significant neurologic or neurodegenerative disorder other than stroke\n* presence of dementia based on dependence in basic ADLs due to cognitive deficits\n* history of psychosis or mania (evaluated using the SCID).\n* active suicide ideation (assessed via the Columbia Suicide Severity Rating Scale)\n* severe executive dysfunction (based on clinical judgment during screening evaluation) precluding use of the iPad\n* severe depression-even in the absence of active suicidal ideation-based on the screening evaluation and clinical judgment of the PI, which warrants a higher level of care and\u002For immediate referral to psychiatric services.\n* pregnancy\n* any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.","50 Years","79 Years",{"count":111,"type":22},70,[113],"PHASE2","Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.",[116,28,117],"Executive Dysfunction","Stroke",{"date":119,"type":33},"2026-08-20",{"date":121,"type":33},"2023-03-01",{"date":123,"type":22},"2027-09-30",{"name":125,"class":40},"Weill Medical College of Cornell University",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":133,"minAge":18,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":75},"100631940","phase-2-optimized-neuroplasticity-enhanced-depression-one-d-transcranial-magnetic-stimulation-tms-treatment-for-female-athletes-with-co-morbid-depression-and-concussion-100631940","NCT07507214","Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion","Optimized, Neuroplasticity Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion","Inclusion Criteria:\n\n* Female athletes, both recreational and professional\n* ages 18-65 years old\n* Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present\n* Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater\n* Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding individuals\n* History of seizures or epilepsy\n* Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)\n* Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)\n* History of bipolar disorder\n* Pacemakers or implanted defibrillators\n* Allergy or other contraindications to d-cycloserine\n* Other contraindications as determined by PI\n* Unable to provide informed consent due to language or other barriers\n* Incarceration\n* Biological male gender","FEMALE","65 Years",{"count":136,"type":22},35,[113,138],"PHASE3","Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits:\n\nPrevious studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.",[141,28],"Concussion","NOT_YET_RECRUITING","2026-08-17",{"date":30,"type":33},{"date":146,"type":22},"2026-09-01",{"date":148,"type":22},"2028-06-01",{"name":150,"class":40},"University of Florida",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":178},"100528589","type-i-hybrid-effectiveness-implementation-trial-of-primary-care-brief-mindfulness-training-for-veterans-100528589","NCT06162741","Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans","Inclusion Criteria:\n\nTo be eligible, participants must be:\n\n* enrolled in VA primary care through the local VA site\n* report clinically significant psychological distress as measured in at least one of three areas:\n\n  * PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor\n  * depression operationalized as 10 on the PHQ-9\n  * anxiety operationalized by 10 on the GAD-7\n\nExclusion Criteria:\n\nExclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:\n\n* gross cognitive impairment\n* suicide attempt or desire to commit suicide in the last month\n\nTo allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:\n\n* had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled\n* had a change in psychiatric medication outside of VHA primary care in the last 2 months\n* voice a preference to be directly referred to specialty mental health care\n\nVeterans with mild TBI, and alcohol\u002F substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.",{"count":158,"type":22},300,[25],"The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and\u002For PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and\u002For PTSD and increase overall functioning.",[162,28,163],"Post Traumatic Stress Disorder (PTSD)","Anxiety",[165,162,166,167,168,28,163,169],"Psychological Distress","Mindfulness","Primary Care","Brief Intervention","Problem-solving training",{"date":32,"type":33},{"date":172,"type":33},"2024-08-19",{"date":174,"type":22},"2027-12-31",{"name":176,"class":177},"VA Office of Research and Development","FED",4,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":187,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":75},"100445527","a-primary-care-based-psychosocial-intervention-to-improve-cognitive--depression-outcomes-in-older-adults-with-mci--early-stage-ad-100445527","NCT05081596","A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD","PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults With MCI and Early Stage AD","PATH-Pain","Inclusion Criteria:\n\n* Age ≥ 60 years old\n* MCI or early stage probable or possible AD diagnosis (as defined by Albert et al or McKhann et al) al). Patients will have at least mild cognitive deficits defined by 16 ≤ MoCA ≤ 25.\n* Montgomery Asberg Depression Rating Scale (MADRS)\\[55\\] total ≥ 5, which reflects at least some mild depressive symptoms.\n* Participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks.\n* Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score \\>=4.\n* Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1.\n* Participant will have capacity to consent.\n* Participation of a study partner (e.g. caregiver\u002Ffamily member\u002Fsignificant other) is required.\n\nExclusion Criteria:\n\n* Deemed to have a significant suicide risk as assessed by site PI and clinical team.\n* Deemed too unstable medically or neurologically to safely enroll in a research trial.\n* Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy.\n* Requiring psychiatric hospitalization at baseline for safety.\n* Lack of English fluency.","60 Years",{"count":189,"type":22},100,[25],"The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.",[28,193,194],"Pain","Cognitive Impairment",[196,197,198],"Older Adults","Mild Cognitive Impairment","Early Stage Alzheimer's Disease",{"date":119,"type":33},{"date":201,"type":33},"2022-06-03",{"date":203,"type":22},"2027-07-31",{"name":125,"class":40},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":75},"100639485","phase-2-allopurinol-in-depression-100639485","NCT07574060","Allopurinol in Depression","Allopurinol Adjuvant Therapy in Patients With Major Depressive Disorder","Inclusion Criteria:\n\nPatients aged greater than 18 years old. Patients with a HAM-D score of at least 10 with item 1, depressed mood, scoring 2 or greater, are eligible.\n\nExclusion Criteria:\n\nPatients with bipolar I or bipolar II disorder Patients with eating disorders Pregnant women or women not using medically accepted means of birth control Cardiovascular disorders Severe renal impairment",{"count":111,"type":22},[113,138],"Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients.",[28],"2026-08-16",{"date":30,"type":33},{"date":219,"type":33},"2026-05-20",{"date":221,"type":22},"2027-05-20",{"name":223,"class":40},"Tanta University",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":230,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":75},"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.",true,"70 Years",{"count":233,"type":22},64,[235],"PHASE1","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",[28],[239,240,241,28],"PET Imaging","Inflammation","Cyclooxygenase-2","2026-08-15",{"date":30,"type":33},{"date":245,"type":33},"2021-07-20",{"date":247,"type":22},"2030-04-11",{"name":249,"class":250},"National Institute of Mental Health (NIMH)","NIH",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":230,"sex":17,"minAge":257,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":261,"phases":4,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":41},"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":260,"type":22},4100,"OBSERVATIONAL","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....",[28],[265,266,267,268,269,270],"Cognitive Behavior Therapy","Mood Disorder","Biomarkers","Mechanism","Major Depressive Disorder (MDD)","Natural History",{"date":30,"type":33},{"date":273,"type":33},"2017-12-28",{"date":275,"type":22},"2027-07-01",{"name":249,"class":250},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":295,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":312},"100577061","phase-3-a-study-of-a-deuterated-psilocin-analog-cyb003-in-humans-with-major-depressive-disorder-100577061","NCT06793397","A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder","An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder","EMBRACE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.\n* Participant has a body mass index (BMI) of 40 kg\u002Fm2 or less (BMI ≤40 kg\u002Fm2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.\n* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.\n* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded from trial participation:\n\n* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.\n* Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.","85 Years",{"count":287,"type":22},330,[138],"The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.\n\nFor more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https:\u002F\u002Fembrace-mdd-trial.com\u002F",[269,291,292,293,294,28],"Depression in Adults","Depression - Major Depressive Disorder","Depression Disorders","Depression Disorder",[296,297,28,57,298,299,300,301,302],"MDD","Psychedelic","CYB003","CYB003-001","CYB003-002","Psilocybin","psilocin-7438","2026-08-14",{"date":143,"type":33},{"date":306,"type":33},"2025-12-10",{"date":308,"type":22},"2027-05-08",{"name":310,"class":311},"Cybin IRL Limited","INDUSTRY",68,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100564967","digital-integrated-behavioral-treatment-for-comorbid-obesity-and-depression-among-racial-and-ethnic-adults-age-50-and-older-100564967","NCT06636058","Digital InteGrated Behavioral treatmeNt for Comorbid obesITy and deprEssion Among Racial and Ethnic Adults Age 50 and Older","Digital InteGrated Behavioral treatmeNt for Comorbid obesITy and deprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)","IGNITE","Inclusion Criteria\n\n* Age 50-74 years (inclusive)\n* Confirmed body mass index (BMI) between ≥27.0 and \\\u003C45.0 based on weight and height measured by study staff at device distribution\n* Confirmed weight ≤396 lbs\n* Patient Health Questionnaire-9 (PHQ-9) scores between ≥10 and \\\u003C20, indicating moderate to moderately severe depressive symptoms\n* Self-identified race and ethnicity other than non-Hispanic White\n* Willing and able to accept randomization, and provide informed e-consent and HIPAA authorization\n\nExclusion Criteria\n\n* Unable to speak, read, understand English sufficiently for informed consent\n* No reliable Wi-Fi Internet access at home\n* Pre-existing type 1 or type 2 diabetes, coronary heart disease, heart failure, stroke, cancer diagnosis (other than non-melanoma skin cancer) or treatment in the past 12 months, end-stage organ failure, residence in a long-term care facility, life expectancy \\\u003C24 months\n* Self-report of weight change \\>15 lbs. during prior 3 months\n* Current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other programs led by trained personnel (professional or lay) at the recruiting clinic or in the local community\n* Taking prescription medications regularly that affect appetite\u002Fweight (e.g., anti-obesity medicines, oral corticosteroids, oral hypoglycemics, etc.) for chronic disease management\n* Planned or prior bariatric surgery (Note: patients who are more than 2 years post bariatric surgery may otherwise be eligible)\n* Screen positive for bulimia nervosa using PHQ- eating disorder module\n* Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician clearance to participate\n* Active suicidal ideation (PHQ-9 item 9 score ≥1 or SCL-20 item 2 score ≥2) with active plan and\u002For intent\n* Bipolar or psychotic disorder, or pharmacotherapy or psychotherapy (individual or professionally-led group therapy), or brain stimulation therapy for depression or any other psychiatric condition\n* Cognitive impairment based on the Callahan 6-item screener\n* Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)\n* Current or planned pregnancy or lactating (\\\u003C6 months postpartum)\n* Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss and depression outcomes of this study\n* Family\u002Fhousehold member of an already enrolled participant or of a study team member\n* Investigator discretion for serious safety or protocol adherence reasons","74 Years",{"count":323,"type":22},440,[25],"The goal of this randomized clinical trial is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving therapy virtual coach for depression management with the Diabetes Prevention Program video-based program for weight loss, among racial and ethnic minorities with comorbid depression and obesity. The study aims include:\n\n* Determine the efficacy of the vCare intervention at 6 months. Primary outcomes are weight and depression symptom checklist 20-item (SCL-20) score.\n* Identify predictors of treatment success, defined by achieving clinically significant weight loss (5%) and depression outcomes (50% decline or SCL-20\\\u003C0.5), at 6 and 12 months.\n* Characterize participant experiences and perceptions of the vCare intervention. Eligible participants will be randomized to the early-intervention arm who will receive active treatment for 6 months, followed by maintenance for another 6 months, or the later-intervention arm who will be waitlisted for 6 months and then receive active treatment in the second 6 months.",[327,28],"Obesity",{"date":30,"type":33},{"date":330,"type":33},"2025-01-21",{"date":332,"type":22},"2028-10-13",{"name":334,"class":40},"University of Illinois at Chicago",2,{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":230,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":75},"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":343,"type":22},108,[235],"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",[28],[239,28,348],"Phosphodiesterase-4",{"date":143,"type":33},{"date":351,"type":33},"2023-06-22",{"date":353,"type":22},"2029-04-11",{"name":249,"class":250},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":230,"sex":17,"minAge":18,"maxAge":134,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":75},"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":362,"type":22},150,[235],"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",[366,57,28],"Healthy Volunteer",[368,369,57,370,371],"Magnetic Resonance Imaging","Magnetoencephalography","Ketamine","Neuropharmacology",{"date":143,"type":33},{"date":374,"type":33},"2017-05-25",{"date":376,"type":22},"2028-01-01",{"name":249,"class":250},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":230,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":75},"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":386,"type":22},325,[113],"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...",[390,28],"Healthy Volunteers",[392,393,370,57,267],"Neurobiology","Suicide",{"date":143,"type":33},{"date":396,"type":33},"2015-12-01",{"date":398,"type":22},"2030-07-21",{"name":249,"class":250},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":4},"100652527","codepad-iii-collaborative-outcomes-of-depression-and-pain-associated-with-delivery-iii-100652527","NCT07773259","CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)","Collaborative Psychological Model for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)","CODEPAD-III","Inclusion Criteria (Mothers):\n\n* Healthy (American Society of Anesthesiologists (ASA) physical status II);\n* Parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);\n* With a singleton fetus;\n* Planning to have childbirth and delivery at study site;\n* Patients with prior mental health history, and current active psychiatric care will also be recruited.\n\nInclusion Criteria (Fathers):\n\n* Identified partner (e.g., husband or significant other) of the enrolled pregnant patient;\n* Aged 21 years and above;\n* Able to understand the study procedures and willing to participate in the 8 weeks postpartum assessment.\n\nExclusion Criteria (Mothers):\n\n* History of intravenous drug or opioid abuse;\n* Previous history of chronic pain syndrome.\n\nExclusion Criteria (Fathers):\n\n* Unable to provide informed consent (e.g., cognitive impairment, language barriers without available translation support);\n* Any condition that, in the opinion of the investigators, would make participation inappropriate (e.g., severe psychiatric or medical condition).","21 Years",{"count":410,"type":22},3470,[25],"The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after childbirth.\n\nThe study site proposes a Collaborative Psychological Model (CPM) consisting of music listening, customized mobile application on psychological strategies, telephone-based support, with monitoring (mobile electronic surveys, wearable-based vital sign monitoring) to effectively prevent, detect, monitor, and treat depression and persistent pain after childbirth. The study will determine if using the CPM will reduce the risk of having depression associated with childbirth. The study will also find out whether the CPM will reduce the depressive symptoms in women who undergo labor that may have increased depression risk. This clinical study will involve 2042 women undergoing childbirth at KK Hospital. In addition, up to 1428 patients' partners (fathers) will also be recruited for the week 8 postpartum assessment.\n\nThe study findings will improve healthcare for women in the community by incorporating digital psychological strategies to manage depression and persistent pain after childbirth. The CPM will also guide future directions to customize an individual's healthcare needs and to improve transition from hospital to community care for women after childbirth.",[28,414,193,415],"Postpartum","Mental Health","2026-08-12",{"date":32,"type":33},{"date":419,"type":22},"2026-10",{"date":421,"type":22},"2031-12",{"name":423,"class":424},"KK Women's and Children's Hospital","OTHER_GOV",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":440,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":75},"100531932","the-oh-happy-day-class---digital-connections-ohdc-dc-a-pilot-study-100531932","NCT06206226","The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study","The Oh Happy Day Class - Digital Connections (OHDC-DC): an Exploratory Pilot Study","OHDC-DC","Inclusion Criteria:\n\n* African-American\n* Age 18 and older\n* Experiencing depression (as evidenced by a score of 5 or higher on the PHQ-9)\n* Own a mobile phone\n\nExclusion Criteria:\n\n* Individuals who are currently receiving psychotherapy\n* Individuals who are presently experiencing suicidal ideation\n* Individuals who started psychotropic medication less than three months prior to the start of the OHDC will be excluded from the study\n* Participants scoring 25 or higher on the PHQ-9 will be screened out",{"count":434,"type":22},8,[25],"The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression.\n\nParticipants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.",[28,438,439],"Depressive Disorder","Depressive Symptoms",[441],"African American",{"date":303,"type":33},{"date":444,"type":22},"2026-08",{"date":446,"type":22},"2027-02",{"name":448,"class":40},"University of Wisconsin, Madison",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":230,"sex":133,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":75},"100497921","understanding-the-role-of-doulas-in-supporting-people-with-pmads-100497921","NCT05763537","Understanding the Role of Doulas in Supporting People With PMADs","Inclusion Criteria:\n\n* Participants must be over the age of 18\n* Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment\n* Live in a HRSA-designated rural area of Montana\n\nExclusion Criteria:\n\n* They are under the age of 18\n* Not currently pregnant\n* Not between 13-26 gestational weeks at the time of enrollment\n* If they do not live in a HRSA-designated rural are of Montana.",{"count":456,"type":22},75,[25],"Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.",[460,461,462,463,464,415,465,466,28,467],"Maternal Health","Pregnancy","Delivery, Obstetric","Self Efficacy","Social Support","Substance-Related Disorders","Postpartum Depression","Mental Health Services",{"date":303,"type":33},{"date":470,"type":33},"2024-11-26",{"date":472,"type":22},"2026-12-31",{"name":474,"class":40},"University of Montana",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":490,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":75},"100620556","changing-lives-and-changing-outcomes-9-at-worcester-recovery-center-and-hospital-100620556","NCT07359157","Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital","Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital: Implementing and Evaluating A Mental Illness and Criminal Risk Focused Intervention for People With Serious Mental Illness","CLCO-9","Inclusion Criteria:\n\n* Currently hospitalized at Worcester Recovery Center and Hospital (WRCH)\n* At least 18 years old\n* Self-reported current or past legal involvement\n* Speaks English\n* For patients without a legally authorized representative (LAR): demonstrate capacity to consent per the Capacity Assessment Record (CAR).\n* For patients with an LAR: assent to participate.\n\nExclusion Criteria:\n\n* Hospital status that does not permit group attendance (e.g., room-based seclusion)",{"count":53,"type":22},[25],"People with serious mental illness (depression, bipolar, and schizophrenia spectrum disorders) have high rates of repeated criminal legal involvement and psychiatric hospitalizations. Longstanding research shows that in addition to treating clients' symptoms of mental illness, targeting risk factors for legal involvement can help reduce their chances of future incarcerations. Because hospitals are becoming increasingly forensic, treatment programs that address both mental illness and risk factors for legal involvement may be especially helpful in a state hospital setting, like Worcester Recovery Center and Hospital (WRCH). This treatment study offers an adjunctive 9-session intervention, Changing Lives and Changing Outcomes-9 (CLCO-9), for patients at WRCH; this program is designed to help people with serious mental illness who are involved in the legal system increase their awareness of their mental health and reduce their chances of future legal involvement.\n\nThe investigators are proposing a treatment study testing the use of the CLCO-9 group intervention with patients with serious mental illness with current or previous criminal legal involvement at Worcester Recovery Center and Hospital (WRCH). The study has three aims:\n\n1. Evaluate feasibility, fidelity, and patient satisfaction during the implementation of the CLCO-9 group treatment at WRCH\n2. Evaluate CLCO-9's effectiveness on improving patient's self-reported mental health, and behavioral indicators of mental health and risk factors for legal involvement\n3. Explore changes in WRCH clinicians' knowledge and attitudes about treating risk factors for criminal legal involvement.\n\nTo test these aims, the research team will employ a two-phase study. In the first phase, the researchers will implement the intervention and make necessary adjustments to maximize the success of the implementation. In the second phase, the researchers will evaluate the treatment program's effectiveness in producing change from pre- to post-treatment.\n\nAll patient participants in this study will receive the intervention. The projected sample size is about 20 treatment completers and 4 to 8 group leaders.",[487,488,28,489],"Serious Mental Illness","Psychotic Disorder","Bipolar",[491,492,493,494,495,496],"serious mental illness","criminogenic risk","criminal legal involvement","treatment","forensic","state hospital","2026-08-11",{"date":416,"type":33},{"date":500,"type":33},"2026-02-05",{"date":502,"type":22},"2027-05-01",{"name":504,"class":40},"Massachusetts General Hospital",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":75},"100585192","phase-2-psilocybin-assisted-therapy-for-intergenerational-trauma-100585192","NCT06899165","Psilocybin-Assisted Therapy for Intergenerational Trauma","Processing Intergenerational Trauma With Psilocybin-Assisted Therapy","Inclusion Criteria:\n\n* Age at least 18 years old at time of signing the informed consent.\n* Biological child of at least one parent who directly survived\u002Fescaped a genocide.\n* Evidence of clinically significant intergenerational trauma-related symptoms, as determined by the modified Parental PTSD Questionnaire (mPPQ).\n* Meet diagnostic criteria for a depressive, anxiety, trauma-, or stressor-related disorder on the Structured Clinical Interview for DSM-5 (SCID-5).\n* BMI of ≥ 17.\n* Capable of providing written informed consent and complying with study procedures.\n* If of reproductive potential, willing to use a highly effective method of contraception throughout study participation. Participants who can father a child and have partners of reproductive potential must also agree to use effective contraception throughout study participation.\n* Willing and medically appropriate to discontinue serotonergic medications before study treatment and remain off such medications throughout study participation, as determined by the study physician in consultation with the participant's treating healthcare provider.\n* Fluent in speaking and reading English.\n* Able to swallow pills.\n* Agree to have all study visits (both in-person and remote) recorded with audio and video.\n* Able to provide a contact person who can be reached by investigators in the event of the participant becoming unwell or unreachable.\n* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n* Agree to release relevant medical and psychiatric records for eligibility determination and safety monitoring.\n* Agree to comply with protocol-specified lifestyle restrictions and study requirements.\n\nSafety note (not incl.\u002Fexcl. criteria): Note to Potential Participants: Individuals interested in this study should not stop, taper, or otherwise change prescribed medications before speaking with the study team. Any medication changes required for study participation will be evaluated by qualified study clinicians and, when appropriate, coordinated with the participant's treating healthcare provider.\n\nExclusion Criteria:\n\n* Individual was directly exposed to the genocide.\n* Current or recent illicit drug or prescription drug substance use disorder (excluding cannabis and tobacco use disorders), as determined by DSM-5 criteria and clinical assessment.\n* Current or recent alcohol or cannabis use disorder that, in the opinion of the investigator, may interfere with safe participation or study outcomes.\n* Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months.\n* Recent use of psychedelic substances.\n* Recent non-medical or illicit use of ketamine.\n* Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder.\n* Current serious suicide risk, recent suicidal behavior, or clinician concern that the participant poses a risk to self or others.\n* Acute, severe, or unstable medical illness, including clinical or laboratory evidence of severe renal and\u002For hepatic impairment.\n* Any physical or intellectual disability adversely affecting ability to complete assessments.\n* Current pregnancy or currently chest\u002Fbreastfeeding.\n* Any clinically meaningful abnormal laboratory test result, as determined by the investigator.\n* Current treatment with medications contraindicated with study treatment that cannot be safely tapered, discontinued, or substituted in accordance with the protocol.\n* History of clinically significant QT prolongation or other clinically significant cardiac conduction abnormality.\n* Use of medications known to prolong the QT interval that cannot be safely discontinued.\n* Any congenital prolongation of the QT interval or a family history of long QT syndrome.\n* A family history in a first-degree relative of psychosis\u002Fschizophrenia or related disorders as assessed by clinical interview with Study MD.\n* A first-degree family history of bipolar disorder as assessed by clinical interview with Study MD.\n* Current anorexia nervosa or bulimia nervosa as determined by DSM-V criteria using the SCID-V.\n* A clinically meaningful history of cardiac arrhythmias or who require treatment with an antiarrhythmic medication.\n* Preexisting clinically meaningful cardiovascular conditions, including cardiac valvulopathy, pulmonary hypertension that may be worsened\u002Fexacerbated by elevated blood pressure or heart rate.\n* Neurological conditions including stroke, transient ischemic attack (TIA), epilepsy, neurodegenerative disease, brain tumor, or other neurological disorders that would impact participation in the trial.\n* Insulin-dependent diabetes.\n* Vital sign abnormalities at screening that exceed protocol-defined safety thresholds.\n* Hypersensitivity to psilocybin.\n* Psychiatric or other condition judged to be incompatible with establishment of rapport with therapy team and\u002For safe exposure to psilocybin.\n* Positive toxicology findings not adequately explained by prescribed medications or approved treatment regimens.\n* Clinically meaningful abnormalities on screening electrocardiogram (ECG).\n* Fall risk if not mitigated by assistance from study staff.\n* Can't identify a support person who will be able to accompany them home and stay the night with them post experimental session.",{"count":189,"type":22},[113],"This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.\n\nThe study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.",[516,28,163],"Psychological Stress",[518,519,520,521,522,523],"psilocybin","psilocybin-assisted therapy","intergenerational trauma","psychedelic","stress","genocide",{"date":525,"type":33},"2026-08-13",{"date":527,"type":22},"2026-08-28",{"date":529,"type":22},"2030-01-02",{"name":531,"class":40},"Rachel Yehuda",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":230,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":335},"100651870","virtual-nature-versus-guided-imagery-for-anxiety-and-well-being-in-hospitalized-older-adults-100651870","NCT07765355","Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults","Bottom-Up Virtual Nature Versus Top-Down Guided Imagery in Hospitalized Older Adults: A Randomized Parallel-Group Clinical Trial","Inclusion Criteria:\n\n* Aged 65 years or older\n* Receiving inpatient hospital care, with at least two weeks of hospitalisation at the time of enrolment\n* Montreal Cognitive Assessment (Hungarian version) score of 18 or above, with education correction\n* Physically able to safely wear a head-mounted virtual reality display\n* Adequate corrected or uncorrected vision and hearing\n* Able to communicate in Hungarian\n* Stable psychiatric and cardiovascular condition, as determined from medical history and in consultation with the treating physician\n* Able to provide independent written informed consent\n\nExclusion Criteria:\n\n* Epilepsy with recurrent seizures, or photosensitivity\n* Neurological condition associated with increased risk during virtual reality use, including Meniere's disease and significant carotid stenosis\n* Active psychosis, hallucinations, or severe depression with psychotic features\n* Open wound or skin lesion on the face, chronic neck pain, or spinal condition preventing safe use of the head-mounted display\n* Severe uncorrectable sensory impairment\n* Unstable psychotropic medication during the preceding eight weeks\n* Regular use of analgesic or psychotropic medication that may substantially affect perception of the experience\n* Active alcohol or substance use disorder within the past year\n* Refusal or inability to provide informed consent\n\nEnrolment is deferred, rather than excluded, in the presence of active delirium or infectious illness, until the condition resolves.",{"count":540,"type":22},60,[25],"Long hospital stays can be difficult for older adults. Being confined to a ward, with limited mobility and little access to the outdoors, may contribute to anxiety, low mood, and reduced well-being. Contact with nature is known to support relaxation and emotional recovery, but hospitalized patients often cannot go outside.\n\nThis study compares two ways of bringing a nature experience to patients who are staying in hospital. In the first approach, participants wear a virtual reality headset and watch 360-degree videos filmed in real natural settings near Budapest: a meadow, a stream, and a mountain. The nature scene reaches them through their eyes and ears. In the second approach, participants listen to a short recorded audio guide and picture the same three nature scenes in their own minds, with their eyes closed. Here the nature scene is created by their own imagination.\n\nBoth approaches use exactly the same nature themes. The only difference is how the experience reaches the person: from the outside through the senses, or from the inside through imagination. The study asks whether these two routes have different effects, and whether they can be told apart by measuring heart rate variability, which reflects how the body's automatic nervous system responds.\n\nParticipants are adults aged 65 or older who have been in hospital for at least two weeks. After joining the study, each participant is first observed for two weeks while receiving only their usual hospital care. This period serves as their own comparison. They are then assigned by chance to one of the two approaches and take part in three sessions over two weeks. Questionnaires and brief cognitive tests are completed at three points: when joining, before the sessions begin, and after the sessions end.\n\nThe main question is whether anxiety symptoms decrease more during the session period than during the preceding period of usual care. The study also looks at mood, attention and memory, well-being, and resilience.",[163,544,545,165,28],"Hospitalization","Quality of Life",[547,548,549,550,551,552,553,554,555,556,557],"virtual reality","guided imagery","nature exposure","heart rate variability","hospitalized older adults","top-down processing","bottom-up processing","RMSSD","geriatrics","Katathym Imaginative Psychotherapy","symbol therapy","2026-08-10",{"date":303,"type":33},{"date":561,"type":33},"2025-06-01",{"date":563,"type":22},"2027-01",{"name":565,"class":40},"Semmelweis University",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":75},"100577649","phase-2-trips---treatment-to-improve-depression-andor-anxiety-using-psilocybin-assisted-psychotherapy-in-cancer-survivors-100577649","NCT06801041","TRIPS - Treatment to Improve Depression and\u002For Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors","Inclusion Criteria:\n\n1. Subjects must have solid or hematological malignancy that does not involve the brain.\n2. Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months\n3. Age ≥ 18 years.\n4. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder, Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnoses are determined by. an MD Anderson licensed healthcare provider with graduate-level profession training and clinical experience in psychotherapy, licensed to practice independently.\n5. Have an ECOG performance status of 0, 1, or 2.\n6. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n7. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n8. Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance.\n9. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Patient tested positive for a prescribed substance are eligible. Patient failing on the 2nd test (UDS) will be excluded.\n10. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications for a minimum of 2 weeks prior to study. Intermittent or PRN use of short-acting anxiolytics or and anti-nausea medications (e.g., ondansetron) may be permitted as defined below in exclusionary criteria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n11. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n12. Eligible subjects will have a third-party transportation by a licenses driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home\n13. Fluent in Englishria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n\nExclusion Criteria:\n\n1. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self injurious behavior\n2. History of bipolar disorder, psychosis (including a history of schizophrenia).\n3. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.\n4. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n5. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.\n6. Documentation of current malignancy that is being treated with palliative intent.\n7. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n8. Patients with brain metastases.\n9. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) Blood Pressure \\>blood pressure \\>180\u002F120mmHG, HR \\>110 bpm . Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and \"white coat hypertension.\"\n10. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n11. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm on imaging ii. Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a one-time febrile seizure in childhood iii. History of stroke in the past 3 years iv. Untreated cerebral aneurysm v. Dementia vi. Ongoing delirium in which subjects would not have the capacity to participate in the study.\n\n12 a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>22 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort) viii. efavirenz f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\ni. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\nii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\niii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\niv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.\n\ng. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin.\n\nh. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\ni. Have an allergy or intolerance to any of the materials contained in the drug product.\n\nj. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and\u002For existential distress (e.g., pharmacologic or psychotherapeutic interventions).\n\n13\\. Patients with non-fMRI compatible implants will be eligible but will not have fMRI.",{"count":573,"type":22},20,[113],"This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and\u002For anxiety.",[28,163,577],"Cancer",{"date":416,"type":33},{"date":580,"type":33},"2025-05-23",{"date":582,"type":22},"2029-03-31",{"name":584,"class":40},"M.D. Anderson Cancer Center",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":594,"studyType":261,"phases":4,"briefSummary":595,"conditions":596,"keywords":605,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":75},"100568904","cognitive-impact-associated-with-surgery-for-gastric-or-esophageal-cancer-100568904","NCT06687291","Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer","CASE","Inclusion Criteria:\n\n* Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.\n* Age ≥18 at the time for inclusion.\n* Participate on a voluntary basis and can (for any reason) end its participation during the study.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n* Patients with preoperative cognitive dysfunction such as dementia.\n* Patients who are inoperable due to metastases.\n* Patients unable to communicate due to severely impaired hearing and\u002For - seeing.\n* Patients with ongoing drug and\u002For alcohol abuse.\n* Patients who cannot give informed consent.",{"count":593,"type":22},130,"6 Months","The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia.\n\nParticipants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium.\n\nThe main objective aims to answer:\n\nWhat is the incidence of POD after gastroesophageal cancer surgery.",[597,598,599,600,601,602,603,604,28],"Gastroesophageal Cancer (GC)","Postoperative Delirium (POD)","Quality of Life (QOL)","Frailty","Malnutrition","Sarcopenia","Chemobrain","Chemotherapy",[606,607,600,608,609,601,602,603,604],"postoperative delirium","gastroesophageal cancer","Quality of life","Preoperative depression",{"date":497,"type":33},{"date":612,"type":33},"2025-02-13",{"date":614,"type":22},"2028-11-11",{"name":616,"class":40},"Karolinska Institutet",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":624,"enrollmentInfo":625,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":634,"locationsCount":75},"100494981","tavns-or-tms-or-both-for-depression-100494981","NCT05725239","taVNS or TMS or Both for Depression","Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)","Inclusion Criteria:\n\n* 18-75 years old\n* Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode\n* Able to provide informed consent\n* English speaking and can read and write\n* 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20\n* Not responding to talking therapy.\n\nExclusion Criteria:\n\n* Preexisting neurological disorders, or dementia\n* History of major head trauma\n* Life expectancy \\\u003C1 year\n* Any type of cognitive impairment that would require approval\u002Fsignature of a legal guardian\u002Frepresentative for participation\n* A score of \\>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality\n* Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded\n* Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.","75 Years",{"count":626,"type":22},24,[25],"The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.",[28],{"date":416,"type":33},{"date":632,"type":33},"2023-03-14",{"date":275,"type":22},{"name":635,"class":40},"Medical University of South Carolina",{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":4,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":17,"minAge":643,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":647,"conditions":648,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":75},"100450199","icbt-internet-based-cognitive-behavioral-therapy-for-maternal-depression-community-implementation-in-head-start-100450199","NCT05142384","ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start","ICBT for Maternal Depression: Community Implementation in Head Start","Inclusion Criteria: Mothers\n\n* Elevated symptoms of depression (i.e., Patient Health Questionnaire or Edinburgh Postnatal Depression Scale score at or above 10)\n* Have a child 2-5 years enrolled in a participating Head Start; be able to communicate in English or Spanish.\n\nInclusion Criteria: Child\n\n\\- 2-5 years of age and enrolled in participation Head Start\n\nExclusion Criteria: Mothers\n\n* Evidence of psychosis or other major mental illness or cognitive disability (observed during recruitment or by HS report) that would interfere with meaningful participation\n* Endorsed score of 3 on final item of the PHQ9 or EPDS indicating frequent thoughts of suicide. Could be enrolled at later date if elevated risk ameliorates\n\nExclusion Criteria: Children\n\n* No exclusion criteria","2 Years",{"count":645,"type":22},960,[25],"Low income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. The intervention program also includes live coaching to help the mothers engage and learn the CBT material. Mom-Net has been shown to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment, in earlier controlled trials. In this project the investigators are examining whether access to Mom-Net can be expanded by delivering it in Head Starts (HS).\n\nTo address that broad question, the investigators will focus on two sets of scientific questions:\n\n1. Implementation Questions: e.g., Can HS agencies deliver the program successfully; do HSs choose to sustain the program after the research project ends; what agency characteristics are associated with successful delivery of Mom-Net);\n2. Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching?\n\nHead Start agencies will be randomized to deliver either Mom-Net with the usual high-intensity coaching or with a low-intensity coaching alternative. Within each agency, depressed mothers will be randomized to receive either: 1) Mom-Net program; or 2) Treatment as Usual (TAU;) referral to community mental health providers). Mothers initially assigned to the TAU condition, will have the option of receiving Mom-Net at a later date. Mothers will participate in assessments of depressive symptoms, parenting behavior, and child adjustment at Time 1 (T1; prior to randomization); and Time 2 (T2; after the intervention period) and Time 3 (T3; one year after T1).",[28],{"date":416,"type":33},{"date":651,"type":33},"2022-12-01",{"date":653,"type":22},"2027-03-31",{"name":655,"class":40},"Oregon Research Institute"]