[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,91,0,25,[9,42,71,106,139,165,195,220,246,271,294,320,343,366,387,414,437,465,493,519,548,571,593,617,639],{"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},"100614944","phase-2-a-study-of-brenipatide-in-adult-participants-with-bipolar-disorder-renew-bipolar-1-100614944",false,"NCT07286175","A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)","A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)","Inclusion Criteria:\n\n* Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires\n* Are on stable standard of care medication for bipolar disorder\n\nExclusion Criteria:\n\n* Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:\n\n  * schizophrenia or other psychotic disorder\n  * borderline personality disorder, or\n  * any eating disorder\n* Have type 1 diabetes mellitus, or a history of\n\n  * ketoacidosis, or\n  * hyperosmolar state or coma\n* Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening\n* Are actively suicidal and or deemed to be at significant risk for suicide\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening","ALL","18 Years","75 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.\n\nThe trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.",[28],"Bipolar Disorder","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2025-11-24",{"date":37,"type":22},"2027-11",{"name":39,"class":40},"Eli Lilly and Company","INDUSTRY",87,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"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":51,"type":22},336,[53],"NA","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.",[28,56,57,58,59],"Schizophrenia","Depression","Borderline Personality Disorder","Autism Spectrum Disorder","2026-08-18",{"date":62,"type":33},"2026-08-19",{"date":64,"type":33},"2023-04-03",{"date":66,"type":22},"2028-03-01",{"name":68,"class":69},"University Hospital, Strasbourg, France","OTHER",7,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100585170","enhancing-veteran-clinical-collaboration-in-va-prrcs-100585170","NCT06898879","Enhancing Veteran-Clinical Collaboration in VA PRRCs","Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers","EVCC VPRRC","Inclusion Criteria:\n\n1. Be a Veteran currently receiving Psychosocial Rehabilitation and Recovery Center (PRRC), Mental Health Intensive Case Management (MHICM) and\u002For Behavioral Health Interdisciplinary Program (BHIP) services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)\n2. Meet Substance Abuse and Mental Health Services Administration (SAMHSA) criteria of serious mental illness; i.e., \"having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities,\" based on chart review and clinician consultation if needed\n3. Be fluent and literate in English\n4. Agree to have a subset of VA mental health treatment appointments audiotaped\n\nExclusion Criteria:\n\n1. Primary substance use or organic neurological disorder diagnosis determined by chart review\n2. Are determined by clinician and\u002For study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation\n3. Have a history and\u002For current risk of violence that clinicians and\u002For study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff)",{"count":80,"type":22},119,[53],"Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and\u002For have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.",[56,84,85,28,86],"Schizoaffective Disorder","Delusional Disorder","Major Depressive Disorder",[88,89,90,91,92,93,94,95],"serious mental illness","psychosis","collaborative decision-making","shared decision-making","veterans","recovery","personal recovery","empowerment","2026-08-17",{"date":62,"type":33},{"date":99,"type":33},"2026-08-12",{"date":101,"type":22},"2029-09-30",{"name":103,"class":104},"VA Office of Research and Development","FED",3,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100490713","nimh-rhythms-and-blues-study-a-prospective-natural-history-study-of-motor-activity-mood-states-and-bipolar-disorder-100490713","NCT05669703","NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Aged 8 and older\n3. Probands must have at least one first-degree relative agree to participate\n4. Affected probands must have a lifetime history of a mood disorder\n5. Unaffected probands must have no lifetime history of a mood disorder\n6. In good general health as evidenced by medical history\n7. Agreement to adhere to Lifestyle Considerations throughout study duration\n8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy\n2. People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).",true,"8 Years","70 Years",{"count":116,"type":22},1260,"OBSERVATIONAL","Background:\n\nMood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.\n\nObjective:\n\nTo better understand relationships among physical activity, sleep, and mental health.\n\nEligibility:\n\nPeople aged 8 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.\n\nDesign:\n\nParticipants will be in the study up to 2 years.\n\nFor up to 20 days in a row, at 4 times during the study, participants will:\n\nComplete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.\n\nWear an activity monitor, like a wristwatch, that records how much they move.\n\nWear a light sensor, as a necklace, to record the amount of light in their environment.\n\nSome participants will do additional tests. Twice during the study, for 3 days in a row, they will:\n\nWear monitors to record their temperature, heart rate, and sleep.\n\nProvide saliva samples.\n\nComplete cognitive tasks on their smartphone.\n\nParticipants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.\n\nSome participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.",[28,120,121],"Major Depression","Migraine",[123,124,125,126,127,128],"Mood Disorders","Actigraphy","CIRCADIAN RHYTHMS","Sleep","Ecological Momentary Assessments","Natural History",{"date":130,"type":33},"2026-08-13",{"date":132,"type":33},"2023-11-03",{"date":134,"type":22},"2027-07-31",{"name":136,"class":137},"National Institute of Mental Health (NIMH)","NIH",1,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100533699","phase-3-safety-and-tolerability-trial-of-lumateperone-in-pediatric-patients-with-schizophrenia-bipolar-disorder-or-autism-spectrum-disorder-100533699","NCT06229210","Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder","An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder","Inclusion Criteria:\n\n* Able to provide consent as follows:\n\n  * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;\n  * The patient must provide written assent to study enrollment;\n* Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.\n\nRollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:\n\n  * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n  * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n  * At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n  * At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or\n  * The patient is considered to be an imminent danger to him\u002Fherself or others.","5 Years","17 Years",{"count":149,"type":22},300,[151],"PHASE3","This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.",[56,28,59],[155],"Pediatric","2026-08-11",{"date":130,"type":33},{"date":159,"type":33},"2024-01-25",{"date":161,"type":22},"2032-04-28",{"name":163,"class":40},"Intra-Cellular Therapies, Inc.",61,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":138},"100556739","phase-2-low-amplitude-pulse-seizure-therapy-versus-standard-ultra-brief-right-unilateral-electroconvulsive-therapy-100556739","NCT06529029","Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy","Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation","LAP-ST vs ECT","Inclusion Criteria:\n\n1. Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.\n2. Male or female patients 18 to 90 years of age\n3. Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders\n4. Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item\n5. Use of effective method of birth control for women of child-bearing capacity\n6. Patient is medically stable\n7. No anticipated need to alter psychotropic medications for the duration of the study (except for urgent\u002Femergent situations)\n8. Ability of patient to fully participate in the informed consent process\n\nExclusion Criteria:\n\n1. Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment\n2. Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding\n3. History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment\n4. Implanted devices that make ECT unsafe\n5. Clinical presentation of delirium or dementia\n6. Active substance use disorders within 1 week of randomization\n7. ECT in the past 1 month or prior failure to respond to an adequate course of ECT as deemed by the ECT physician treating the patient or the PI","90 Years",{"count":175,"type":22},30,[25,151],"This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive\u002Fmemory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.",[179,86,180,28],"Suicidal Ideation","Schizo Affective Disorder",[179,182,57,86,180,28,183,184,185,186],"Suicide","Low Amplitude Seizure Therapy","Electroconvulsive Therapy","Neuromodulation","Brain Stimulation","2026-08-09",{"date":99,"type":33},{"date":190,"type":33},"2024-07-03",{"date":192,"type":22},"2026-12-01",{"name":194,"class":69},"Michigan State University",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":112,"sex":17,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":4,"leadSponsor":219,"locationsCount":138},"100059955","evaluation-of-patients-with-mood-and-anxiety-disorders-and-healthy-volunteers-100059955","NCT00024635","Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers","The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers","* INCLUSION CRITERIA:\n* Subjects ages 3 to 99 may enroll in the protocol.\n* Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. Minors will be asked to assent and their parents will sign the consent form.\n\nEXCLUSION CRITERIA:\n\n-Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment, but not including self-help groups).","3 Years","99 Years",{"count":205,"type":22},16000,"The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved ETPB protocols.",[123,208,209,28,57],"Anxiety Disorders","Healthy Volunteers",[211,212,213,214,128],"Screening","Anxiety","Mood","Diagnostic Testing","2026-08-08",{"date":156,"type":33},{"date":218,"type":33},"2001-02-02",{"name":136,"class":137},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":138},"100598441","phase-1-a-study-to-assess-adverse-events-and-how-oral-abbv-932-moves-through-the-body-when-given-with-oral-itraconazole-in-adult-participants-with-bipolar-disorder-100598441","NCT07071532","A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder","A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder","Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg\u002Fm\\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG\n* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0.2).\n\nExclusion Criteria:\n\n* Participants with bipolar I or II disorder subject psychiatric history:\n\n  * Clinical Global Impression-Severity (CGI-S) \\> 4 at Screening or Baseline.\n  * History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.\n  * Major depressive or manic episode within the past 3 months prior to screening.\n  * Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.\n  * History of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.\n* History of suicidal ideation within 1 year prior to study treatment administration as evidenced by answering \"yes\" to any question on the suicidal ideation portion of Columbia Suicide Severity Rating Scale (C-SSRS) at screening and\u002For history of suicidal behavior within 2 years prior to study treatment administration as evidenced by any \"yes\" answer to suicidal behavior questions on the C-SSRS.\n* History with any protocol prohibited medications, supplements, or herbal products, including any psychotropic drug or any drug with psychotropic activity (e.g., antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential) within 14 days or 5 half-lives of the medication (whichever is longer), prior to study treatment administration, with the exception of protocol-allowed medications listed in the protocol, including a total daily dose of ≤ 2 mg\u002Fday lorazepam.","65 Years",{"count":229,"type":22},20,[231],"PHASE1","This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.",[28],[28,235,236],"ABBV-932","Itraconazole","NOT_YET_RECRUITING","2026-08-04",{"date":240,"type":33},"2026-08-06",{"date":32,"type":22},{"date":243,"type":22},"2027-02",{"name":245,"class":40},"AbbVie",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":138},"100635759","senyo-health-app---comorbid-alcohol-use-disorder-treatment-in-individuals-with-bipolar-disorder-using-a-telehealth-collaborative-care-platform-100635759","NCT07556861","Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform","Inclusion Criteria:\n\n1. Age\\>=18 years;\n2. History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type. Can be clinical diagnosis\n3. Ability to read, write, and understand English;\n4. Minimum DAST (1+) or AUDIT-C score (3+)\n5. Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care;\n6. Eligibility determined by ASAM Assessment as completed by a LADC.\n\nExclusion Criteria:\n\n1. Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment;\n2. Needing a higher level of mental health care as demonstrated by ASAM\\[36\\] assessment; - completed by LADC or MD investigators\n3. Already admitted into or about to initiate treatment in another addiction treatment program.\n4. Currently attending High School. (can be 18 though)\n5. Pregnancy confirmed by self-report\n6. Inability to provide written informed consent.\n7. Inability to understand English.\n8. Clinically unstable medical disease.\n9. Otherwise excluded for administrative reasons and\u002For clinician judgment.",{"count":253,"type":22},40,[53],"The purpose of this study is to examine the effectiveness of a digital integrated behavioral health (IBH) platform in improving alcohol use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder.",[28],[258,259,260,261],"Bipolar","Substance Use","SUD","Alcohol","2026-07-30",{"date":264,"type":33},"2026-07-31",{"date":266,"type":22},"2026-09-16",{"date":268,"type":22},"2029-01-20",{"name":270,"class":69},"Mayo Clinic",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":138},"100502884","prediction-on-the-recurrence-of-manic-and-depressive-episodes-in-bipolar-disorder-100502884","NCT05828056","Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder","Inclusion Criteria:\n\n* DSM-5 Bipolar disorder or depressive disorder\n* 20\\~60 years old\n* Willing to carry smartwatch and smartphone most of the time\n\nExclusion Criteria:\n\n* Comorbid with substance use disorder\n* Unable to use smartwatch and smartphone","20 Years","60 Years",{"count":280,"type":22},100,"Mood disorders (including bipolar disorder and major depressive disorder) are chronic mental disorders with high recurrent rate. The more the number of recurrence is, the worse long-term prognosis is. This study aims to establish a prediction model of recurrence of manic and depressive episodes in mood disorders, with a hope to detect recurrence relapse as early as possible for timely clinical intervention. We will adopt wearable smart watch to collect heart rate, sleep pattern, activity level, as well as emotional status for one year long in 100 patients with bipolar disorder, and annotated their mood status (i.e., manic episode, depressive episode, and euthymic state). We expect to establish prediction models to predict the recurrence of mood episodes.",[28,283],"Depressive Disorder",[285,286],"biomarker","Bipolar disorder",{"date":264,"type":33},{"date":289,"type":33},"2020-03-02",{"date":291,"type":22},"2027-12-31",{"name":293,"class":69},"National Taiwan University Hospital",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":138},"100634037","venous-tourniquet-vs-arterial-tourniquet-for-seizure-monitoring-in-ect-100634037","NCT07534475","Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT","Comparison of Venous Tourniquet Method With Isolated Forearm Technique in Electroconvulsive Therapy in Terms of Efficacy and Safety","Inclusion Criteria:\n\n* Patients scheduled for elective Electroconvulsive Therapy (ECT).\n* ASA (American Society of Anesthesiologists) physical status I to III.\n\nExclusion Criteria:\n\n* Known neuromuscular diseases (e.g., Myasthenia Gravis).\n* Known allergy or hypersensitivity to sugammadex, rocuronium, ketamine, dexmedetomidine, or propofol.\n* Presence of venous insufficiency, lymphedema, or active infection in the upper extremities.\n* Severe cardiovascular instability.",{"count":229,"type":22},[53],"This prospective, open-label clinical trial aims to compare a novel \"Venous Tourniquet with Regional Low-Dose Sugammadex\" method against the gold standard \"Arterial Tourniquet\" (Isolated Forearm Technique - IFT) for monitoring motor seizure activity during Electroconvulsive Therapy (ECT). Using a within-subject (intra-individual) design, each of the 40 enrolled patients will receive an arterial tourniquet on one arm and a venous tourniquet on the other arm simultaneously. The study will evaluate clinical efficacy in observing motor seizures, comparing the duration and visibility between the two limbs of the same patient, as well as assessing overall patient comfort and hemodynamics.",[86,28,56],[184,306,307,308,309,310],"Isolated Forearm Technique","Sugammadex","Neuromuscular Blockade","Seizure Monitoring","Tourniquet","2026-07-24",{"date":313,"type":33},"2026-07-27",{"date":315,"type":33},"2026-04-20",{"date":317,"type":22},"2026-12-20",{"name":319,"class":69},"Medipol University",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":327,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":329,"conditions":330,"keywords":335,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":138},"100624560","emotional-eating-sleep-quality-mental-state-and-metabolic-syndrome-100624560","NCT07411222","Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome","The Mediating Role of Emotional Eating and Sleep Quality in the Relationship Between Mental State and Metabolic Syndrome in Individuals With Schizophrenia and Bipolar Disorder","Inclusion Criteria:\n\n* Being registered with the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center,\n* Having a severe chronic psychiatric illness (Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar Disorder) followed by the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center for at least 6 months,\n* Being in remission (Complete Remission (Pre-Remission): Symptoms remaining below threshold values for at least 2 months (8 weeks). A state of improvement lasting more than 2 months is generally referred to as \"remission\"),\n* Schizophrenia remission definition: 8 diagnostically significant symptoms were selected from the Positive and Negative Syndrome Scale.\n* Bipolar disorder remission definition: Complete remission is defined as the absence of acute attacks and the presence of minimal\u002Fvery mild symptoms.\n* Being between 18-65 years of age,\n* Being able to understand what is read and give written consent.\n\nExclusion Criteria:\n\n* Having a diagnosis of mental retardation,\n* Having other neurocognitive disorders, primarily dementia, according to DSM-V (as it can affect the ability to make decisions and give correct answers),\n* Not being able to speak or understand Turkish.",{"count":328,"type":22},78,"In predominantly medication-naïve schizophrenic patients, those exhibiting partial metabolic disorders have significantly worse sleep quality and sleep onset time; poor sleep predicted metabolic dysregulation even after controlling for confounding factors. Mental health, sleep, and eating behavior interact in ways that strongly influence the risk of obesity and MetS. Emotional eating (eating in response to emotions rather than hunger) is central to this network and appears to be closely associated with psychiatric illnesses, particularly depression, anxiety, and sleep disorders. There is a continuing need to elucidate the frequency, level, and relationship of emotional eating with other factors in individuals with SMI. Therefore, this study aims to elucidate this complex relationship, thereby shedding light on new ways to reduce metabolic risks in psychiatric patients.",[56,28,331,332,333,126,334],"Psychiatric Issue","Metabolic Syndrome","Emotional Eating","Mediating",[56,28,332,333,126],{"date":313,"type":33},{"date":338,"type":33},"2026-05-30",{"date":340,"type":22},"2026-12",{"name":342,"class":69},"Abant Izzet Baysal University",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":350,"maxAge":227,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100537187","intermittent-theta-burst-stimulation-itbs-for-emotion-regulation-in-bipolar-disorder-100537187","NCT06274567","Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder","Targeting Emotion Regulation in Bipolar Disorder With Intermittent Theta Burst Stimulation: A Mechanistic Study","Inclusion Criteria:\n\n1. Individuals of all genders\n2. ages 24-65\n3. Diagnostic Statistical Manual (DSM-5) defined diagnosis of bipolar I or II disorder (BD); assessed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.2.\n4. Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,\n5. Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider\n6. Stable medication regimen for at least one month, which must include a mood stabilizer\n\nExclusion Criteria:\n\n1. current mania\u002Fhypomania assessed by the Young Mania Rating Scale (YMRS \\> 12)\n2. rapid-cycling bipolar illness, defined as \\>4 episodes per year, indicating increased risk of switch to mania\n3. current active suicidality (suicidal ideation with intent or plan), as assessed by a score \\>4 on the MADRS item #10\n4. current substance use disorder for the past 6 months; substance use disorder in remission permitted\n5. history of psychosis\n6. dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \\\u003C24 and Montreal Cognitive Assessment (MOCA) score \\\u003C26\n7. medical illness or non-psychiatric medical treatment that would likely interfere with study participation\n8. contraindications for magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates, non-removable body piercings, etc.), history of seizure disorder, history of head trauma\n9. a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months\n10. current use of benzodiazepines, which can interfere with iTBS stimulation\n11. current pregnancy, to limit potential risks to an unborn child\n\nOther: Given that \\>86% of BD patients experience lifetime comorbid anxiety, co-occurring anxiety disorders will be allowable for inclusion, thus providing a more representative sample of bipolar patients who typically present at our Clinics for treatment. Comorbid anxiety disorders are not a criteria for inclusion or exclusion.","24 Years",{"count":352,"type":22},136,[53],"The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions\u002Fday, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks.",[28],"2026-07-15",{"date":358,"type":33},"2026-07-16",{"date":360,"type":33},"2024-09-20",{"date":362,"type":22},"2029-03-31",{"name":364,"class":69},"Massachusetts General Hospital",2,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":138},"100559178","physical-exercise-for-cognitive-rehabilitation-of-patients-with-bipolar-affective-disorder-100559178","NCT06560749","Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder","Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder: a Controlled and Randomized Study","Inclusion Criteria:\n\n* Diagnosis of Bipolar disorder (BD) I and II according to DSM-5\n* Age: 18 - 55 years old\n* Complete primary education\n* Euthymic (YMRS \\\u003C 8 and MADRS \\\u003C 12)\n* Presence of cognitive impairments (COBRA \\> 14 and SCIP \\\u003C 75)\n* Estimated IQ ≥ 80\n* No medication changes in the last month\n* Having been without regular PE practice for six months\n* Signature of the TCLE\n\nExclusion Criteria:\n\n* Organic mental disorder\n* BMI \\> 40\n* Alcohol or drug abuse in the last 6 months\n* Use of benzodiazepines or beta-blockers in the last month",{"count":374,"type":22},72,[53],"The goal of this clinical trial is to evaluate the impact of Physical Exercise (PE), as an adjuvant treatment, on the cognition of patients diagnosed with Bipolar Disorder who present cognitive impairments, as well as its impact on quality of life and functionality and its association with physiological variables.\n\nOur specific goals are:\n\n1. Evaluate the effect of PE on the neuropsychological functions of attention, memory, verbal fluency, executive function and processing speed in patients diagnosed with BD who present cognitive impairments in these domains.\n2. To evaluate the effect of PE on the quality of life and functionality of patients diagnosed with BD, as well as possible associations with cognitive functions.\n3. To evaluate possible correlations between physiological variables, such as cardiorespiratory indices, strength and body composition, and improvements in cognitive functions, quality of life and functionality.",[28],[28],"2026-07-14",{"date":358,"type":33},{"date":382,"type":33},"2024-08-20",{"date":384,"type":22},"2027-09",{"name":386,"class":69},"Beny Lafer",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":394,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":396,"conditions":397,"keywords":403,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":138},"100645863","the-effect-of-comorbid-alcoholsubstance-use-100645863","NCT07692984","The Effect of Comorbid Alcohol\u002FSubstance Use","The Effect of Comorbid Alcohol\u002FSubstance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Having a diagnosis of Schizophrenia Spectrum Disorder and Other Psychotic Disorders or Bipolar Disorder according to DSM-5 diagnostic criteria,\n* Being actively followed up at the TRSM for at least 6 months.\n\nExclusion Criteria:\n\n* Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),\n* Individuals with severe cognitive impairment that prevents them from communicating adequately.",{"count":395,"type":22},297,"Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions.\n\nAim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use.\n\nResearch Questions\n\nWhat are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD?\n\nHypotheses\n\nH1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use.\n\nH2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group.\n\nH3: Social inclusion is lower among patients with substance use compared with the control group.\n\nH4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone.\n\nH5: Substance use negatively affects patients' social participation, including involvement in activities and friendships.\n\nH6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.",[398,399,400,401,56,28,402],"Alcohol Abuse","Alcohol Use Disorder","Substance Use Disorders","Severe Mental Disorder","Ostracism",[404,400,401,405],"alcohol use disorder","ostracism","2026-07-10",{"date":408,"type":33},"2026-07-13",{"date":410,"type":33},"2026-06-20",{"date":412,"type":22},"2026-12-30",{"name":342,"class":69},{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":138},"100636837","evaluating-the-impact-of-ketogenic-therapy-on-symptom-severity-and-metabolic-side-effect-profile-among-individuals-living-with-bipolar-disorder-in-a-rural-southern-catchment-area-100636837","NCT07570875","Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area","Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area - A Four-Arm Pilot Study","Inclusion Criteria:\n\n* Age \\>18\n* Verified Bipolar Diagnosis per NETSCID\n\nExclusion Criteria:\n\n* Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)\n* Anorexia\n* Pregnancy\n* Severe renal insufficiency\n* Hepatic insufficiency",{"count":280,"type":22},[53],"It is the purpose of this pilot study to evaluate a high-fat\u002Flow-carbohydrate \"ketogenic\" diet-based intervention as an adjunctive strategy for impacting symptoms of bipolar disorder. The study is designed to evaluate this impact in the rural southern catchment area around Montgomery, Alabama.\n\nWhile existing access and cost barriers can prevent effective treatment of bipolar disorder in the rural south, using food as medicine represents a possible alternative\u002Fadjunctive to traditional high-cost\u002Flow-access medications. Specifically, this study will evaluate the impact of combining a ketogenic diet with existing treatment options, under the conditions of the rural catchment area, to determine the impact and efficacy of this intervention at patient and systems levels.\n\nIf effective, the interventions examined in this pilot study may increase the efficacy, availability and access to care experienced by individuals living with bipolarity in the rural Deep South.",[28],[426,427,428],"ketogenic","long-acting injectable","rural","2026-06-30",{"date":431,"type":33},"2026-07-02",{"date":433,"type":22},"2026-08",{"date":340,"type":22},{"name":436,"class":69},"University of Alabama at Birmingham",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":446,"conditions":447,"keywords":451,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":138},"100520649","premorbid-personality-profile-of-patients-with-cognitive-and-behavioral-disorders-100520649","NCT06059313","Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders","Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders","Inclusion Criteria :\n\n* Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria\n* Score for Mini-mental state examination ≥ 18\n* Patient with caregiver who has who has known him\u002Fher in the 10 years preceding the disease onset.\n* Patient and caregiver consents (no opposition)\n\nExclusion Criteria :\n\n* Patient with no caregiver\n* Pregnant or breast feeding women",{"count":445,"type":22},120,"Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.\n\nThe study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral\u002Fpsychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.",[448,449,450,28],"Behavioral Variant of Frontotemporal Disorder (bvFTD)","Phenocopy Frontotemporal Dementia (phFTD)","Frontal Variant of Alzheimer Disease",[452,453,454,455],"bvFTD","fvAD","phFTD","bipolar disorder,personality","2026-06-25",{"date":458,"type":33},"2026-06-29",{"date":460,"type":33},"2023-12-14",{"date":462,"type":22},"2026-12-14",{"name":464,"class":69},"Nantes University Hospital",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":492},"100603776","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-adjunctive-karxt-for-the-treatment-of-mania-with-or-without-mixed-features-in-participants-with-bipolar-i-disorder-taking-lithium-valproate-or-lamotrigine-100603776","NCT07140913","A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","Inclusion Criteria:\n\n* Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.\n* Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).\n* The individual requires hospitalization for the acute exacerbation or relapse of mania.\n* Body mass index ≥ 18 and ≤ 40 kg\u002Fm2.\n* Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.\n* YMRS Total Score of ≥ 18 at Screening and at Baseline, and \\\u003C 20% reduction in YMRS from screening to baseline.\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.\n* Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.\n* Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer \"Yes\" to item 4 or 5 within 6 months before screening or between screening and baseline, or \"Yes\" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.\n* History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.\n* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.\n* Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and\u002For active hepatic viral infections based on either medical history or the LFT results.\n* Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and\u002For bilirubin \\> 1.5× ULN, unless in the context of Gilbert's syndrome.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":473,"type":22},424,[151],"The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.",[477,28],"Mania",[479,477,480,481,482],"Bipolar-I Disorder","KarXT","adjunctive treatment","mood stabilizer","2026-06-22",{"date":485,"type":33},"2026-06-23",{"date":487,"type":33},"2025-10-08",{"date":489,"type":22},"2027-06-28",{"name":491,"class":40},"Bristol-Myers Squibb",104,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":518},"100601024","phase-4-a-study-to-evaluate-the-effectiveness-of-valbenazine-in-adult-participants-with-tardive-dyskinesia-td-who-remain-symptomatic-while-receiving-or-after-stopping-a-vesicular-monoamine-transporter-2-vmat2-inhibitor-100601024","NCT07105111","A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","Key Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder\n* Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening\n\nKey Exclusion Criteria:\n\n* Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD\n* Diagnosis of moderate or severe substance use disorder in the last 6 months\n* History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment",{"count":501,"type":22},50,[503],"PHASE4","This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.",[56,84,28,86,506],"Tardive Dyskinesia",[508],"Valbenazine","2026-06-15",{"date":511,"type":33},"2026-06-16",{"date":513,"type":33},"2025-08-29",{"date":515,"type":22},"2027-01",{"name":517,"class":40},"Neurocrine Biosciences",22,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":527,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":535,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":547},"100606204","phase-3-a-randomized-study-of-azetukalner-versus-placebo-in-depressive-episodes-associated-with-bipolar-i-or-ii-disorder-bipolar-depression-100606204","NCT07172516","A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","X-CEED","Key Inclusion Criteria:\n\n* Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.\n* Body Mass Index (BMI) ≥18 kg\u002Fm2 and ≤40 kg\u002Fm2.\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).\n* Current MDE must has a duration of ≥4 weeks and ≤12 months.\n\nKey Exclusion Criteria:\n\n* Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.\n* Participant has any nonbipolar psychiatric diagnosis.\n* Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.\n* Participant has a symptomatic eating disorder within the 12 months prior to screening visit.\n* Participant has a Young Mania Rating Scale (YMRS) score \\>12 points at screening visit or randomization.\n* Participant has been hospitalized for mania within the 30 days prior to screening visit.\n* Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).\n* Participant has had an active suicidal plan\u002Fintent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.\n* Participant has self-injurious behavior without intent to die in the 12 months prior to screening.\n* Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.\n* Participants with medical conditions that may interfere with the purpose or conduct of the study.\n* Participant is pregnant, breastfeeding, or planning to become pregnant.","74 Years",{"count":21,"type":22},[151],"X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).",[28,532,533,534],"Bipolar Depression","Bipolar I Disorder","Bipolar II Disorder",[258,536,537],"XEN1101","Azetukalner","2026-06-01",{"date":540,"type":33},"2026-06-03",{"date":542,"type":33},"2025-08-08",{"date":544,"type":22},"2028-08",{"name":546,"class":40},"Xenon Pharmaceuticals Inc.",28,{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":138},"100493005","personalized-mobile-cognitive-behavioral-therapy-application-100493005","NCT05699525","Personalized Mobile Cognitive Behavioral Therapy Application","Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression","Inclusion Criteria:\n\n* Age between 18 and 25 years.\n* Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS).\n* If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode.\n* Access to an Apple iPhone, iPad, or Android device.\n\nExclusion Criteria:\n\n* History of neurologic disorder that may affect the neural systems of interest or participant's ability to participate\n* Lifetime diagnosis of a psychotic disorder.\n* Current hypomanic or manic episode.\n* Currently in cognitive behavior therapy.\n* Change in dose of a psychiatric medication in the past 12 weeks.\n* Initiation of psychotherapy in the past 12 weeks.\n* Intent or plan to attempt suicide.","25 Years",{"count":280,"type":22},[53],"This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.",[560,57,28,561],"Anxiety Disorders and Symptoms","Symptoms","2026-05-19",{"date":564,"type":33},"2026-05-22",{"date":566,"type":33},"2024-08-02",{"date":568,"type":22},"2027-07",{"name":570,"class":69},"Weill Medical College of Cornell University",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":112,"sex":17,"minAge":579,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":592},"100276446","immuno-genetic-inflammation-retro-virus-environment-100276446","NCT02878408","Immuno-Genetic, Inflammation, Retro-Virus, Environment","Immuno-Génétique, Inflammation, Retro-Virus, Environnement","I-Give","Inclusion Criteria:\n\n* Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)\n\nExclusion Criteria:\n\n* pregnant women\n* Vaccination within 4 precedent weeks\n* Severe neurologic illness\n* Immunosuppressing or immuno-modulating treatment.\n* Infectious disease within 4 precedent weeks (including HIV 1 et 2, Hepatite B, C)\n* Refuse to have HIV and hepatite B et C tests or to be informed of their results","16 Years",{"count":581,"type":22},1100,[53],"Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far missing in psychiatry, and to design innovative treatment approaches based on the discovery of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to be significantly associated with neuro-inflammation, the project I-GIVE will combine multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between susceptibility to environmental factors (such as winter-spring births, infections, urbanicity…) and genetic factors controlling immune responses.\n\nThus I-GIVE will allow identification of new biomarkers and their correlation with clinical profiles and immuno-inflammatory\u002Fimmuno-genetic markers, and description of patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to design innovative treatments and foster personalized psychiatry tailored to the needs of each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical model for their ability to slow, stop, or even reverse the progression of the psychosis in patients. I-GIVE project should thus lead to major results that will have strong impacts on the scientific community, pharmaceutical industries and, in a longer term, on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.",[28,56],{"date":564,"type":33},{"date":587,"type":33},"2014-11-07",{"date":589,"type":22},"2028-11",{"name":591,"class":69},"Pr. Marion Leboyer",6,{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":615,"locationsCount":138},"100533454","phase-2-correcting-circadian-rhythms-to-breakthrough-in-bipolar-disorder-100533454","NCT06226025","Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for bipolar disorder (BD) I or II\n* Evening chronotype per the Morningness-Eveningness Questionnaire (MEQ) defined by a score of \\\u003C42\n* At least mild depressive symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5\n* Psychotropic medications at stable dose for past month\n* Able to download the MyDataHelps mobile application (app), and open app on participants' own phone\n* Willing to abstain from alcohol for the duration of the intervention phase\n* Female participants of childbearing potential (i.e., patients are not permanently sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or postmenopausal (12 months with no menses without an alternative medical cause) by report) must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.\n\nExclusion Criteria:\n\n* Current diagnosis of, or high risk for, a sleep disorder other than DSPD per interview and medical record review (when available) including:\n\n  * Insomnia per DSM-5\n  * Sleep-disordered breathing per Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP-BANG)\n  * Restless leg syndrome per sleep interview\n  * Narcolepsy\n  * Suspicion of vasomotor symptoms impacting sleep per interview for women that may be perimenopausal or postmenopausal.\n* Risk of current mania (per Young Mania Rating Scale (YMRS) score \\> 19).\n* Suicidal or at high risk for suicide per Columbia Suicide Severity Rating Scale (C-SSRS) guidelines (i.e., presence of any suicidal behavior-suicide attempt, interrupted attempt, abort attempt, or preparatory behavior-in the past 3 months; and\u002For current active suicidal ideation with any intent), or as determined by the principal investigators.\n* Presence of cardiac implantable electronic device, such as defibrillator or pacemaker.\n* Presence of chronic psychiatric conditions which may directly influence sleep per interview and medical record review (when available), including:\n\n  * Current illicit drug use per the Drug Use Disorders Identification Test (DUDIT) defined by a score of ≥ 25\n  * Current alcohol or drug abuse per the Alcohol Use Disorder Identification Test (AUDIT) defined by a score of ≥ 16 and DUDIT\n  * Currently experiencing psychosis\n* Presence of unstable chronic medical condition which may directly influence sleep:\n\n  * Chronic pain\n  * Thyroid conditions\n* Current or history of medical conditions which may be affected by melatonin per self-report and medical record review (when available), such as:\n\n  * Hypertension or hypotension\n  * Diabetes Type 1 or Type 2\n  * Clotting\u002Fbleeding disorders\n  * Epilepsy\u002Fseizures\n  * Autoimmune disorders\n  * Conditions requiring immunosuppressive management such as transplant\n* Per self-report or medical record review (when available), current use of medications which may have interactions with melatonin (see protocol for more details).\n* Current use of medications that may interfere with the measurement of melatonin (non-steroidal anti-inflammatory drugs if used daily, and beta-blockers), per self-report and medical record review (when available).\n* Self-report use of melatonin in the past month.\n* Hypersensitivity to melatonin or any other component of the melatonin or placebo product.\n* Pregnancy (as determined by dipstick urinary pregnancy test at screening for women of child-bearing potential) or self-report of breastfeeding and\u002For plan to become pregnant in the next 3 months.\n* Self-report of routine night shift work.\n* Self-report of past month travel or planned travel during the study across more than one time zone.",{"count":501,"type":22},[25],"The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo.\n\nThe hypotheses for this study include:\n\n* Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment.\n* Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.",[28,603],"Delayed Sleep-Wake Phase Disorder",[605,606,607,608],"Correcting Circadian Rhythms","Melatonin","Placebo","Dim light melatonin onset","2026-05-07",{"date":611,"type":33},"2026-05-11",{"date":613,"type":33},"2024-08-13",{"date":340,"type":22},{"name":616,"class":69},"Leslie Swanson",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":623,"maxAge":227,"enrollmentInfo":624,"targetDuration":4,"studyType":23,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":635,"leadSponsor":637,"locationsCount":138},"100499654","phase-2-the-impact-of-ampa-receptor-blockade-on-ketamines-anti-suicidal-effects-100499654","NCT05786066","The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects","Inclusion Criteria:\n\n* Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale (HDRS-17) AND current major depressive episode as determined by structured clinical interview (SCID-5)\n* Current suicidal ideation as indicated by a score ≥ 2 on the HDRS-17 Item #3 (\"wishes to be dead (or any thoughts of possible death to self)\")\n* Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials\n* Participants will meet DSM-5 Criteria for MDD, PTSD or Bipolar Disorder as determined by the SCID-5\n* All participants given Ketamine must be engaged in mental health treatment outside of the research protocol. Those who are not receiving treatment with a mental health provider at the time of the phone screen may be referred for treatment and will have their admission to the protocol deferred until they are receiving treatment with a mental health provider for at least 4 weeks, at which time they may re-apply for admission to the protocol.\n* Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. Those who are not stable on their current medication and dose for 4 weeks at the time of the phone screen may have their admission to the protocol deferred until they are stable on their current psychopharmacotherapy. In addition, all individuals admitted to the protocol should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.\n* Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial. Those who are not stable on their current regime of psychotherapy for 4 weeks at the time of the phone screen may have their admission to the protocol deferred until they are stable on their current regime of psychotherapy.\n* Willing to refrain from caffeine, drug, and alcohol use for one week prior to each Ketamine infusion\n* Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy). Women who are surgically sterile or post-menopausal with cessation of menses for at least one year are not required to use birth control. If a woman should become pregnant during the study, she will be excluded from the trial.\n* Females will receive Ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps during this entire follicular phase, she will be studied during another part of her cycle. She will be studied during the same part of her cycle for each scan, if possible.\n* Able to read and write English\n* Have at least a 12th grade education level or equivalent\n\nExclusion Criteria:\n\n* A score on the Columbia-Suicide Severity Rating Scale \\[43\\] in the \"intent\" or \"intent with plan\" categories within the last 3 months or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.\n* Psychiatric hospitalization in the past two months\n* Suicide attempt in the past two months\n* Neurological disorder excluding migraine headaches or mild head injury. More than mild head injury is indicated by the presence of any of the following:\n\n  * More than half hour unconsciousness after trauma\n  * More than one hour post-traumatic amnesia\n  * Concussive symptoms such as headache, memory problems, nausea\u002Fvomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.\n  * Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.\n  * Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.\n* Current therapeutic treatment with Ketamine\n* Previous trial of Ketamine without therapeutic benefit\n* Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization\n* Daytime use of benzodiazepines\n* Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization\n* Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization\n* Psychosis other than psychotic experiences congruent with depressed mood during a period of depression. Individuals experiencing psychosis during the current depressive episode will be excluded.\n* Other major medical disorder unless cleared by a study physician\n* History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable sobriety with no violent incidents or an individual who had received successful pharmacotherapy for impulse control difficulties may be included.\n* Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to screening date may be included in the study at investigator discretion. The diagnosis of mild alcohol use disorder shall be per DSM-5 and involve 2-3 symptoms. The PI's discretion will be based on the symptoms that are reported and the judged consistency and accuracy of the subjects' self-report.\n* A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the infusion visits.\n* A positive screening alcohol breathalyzer or alcohol saliva test or, at the study physicians' discretion, on any alcohol breathalyzer or alcohol saliva test given before the infusion visits.\n* A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.\n* Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the study physician considers that such findings will not introduce additional risk factors.\n* History of positive HIV or Hepatitis B\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the Ketamine infusion visit. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinions of the Principal\u002FCo-Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Known sensitivity to Ketamine or heparin\n* Resting blood pressure lower than 85\u002F55 or higher than 140\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin, unless cleared by study physician. If a subject meets these blood pressure entrance criteria, but is being treated for high blood pressure, the study team will check with the subject's primary care physician or treatment provider to confirm that the subject is stable and normotensive on their current treatment plan.\n* History of general intellectual disability\n* Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.\n* Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.","21 Years",{"count":175,"type":22},[25],"The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).",[283,86,28,628,179],"Post Traumatic Stress Disorder",[630,182],"Ketamine","2026-05-05",{"date":633,"type":33},"2026-05-06",{"date":64,"type":33},{"date":636,"type":22},"2033-03",{"name":638,"class":69},"Yale University",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":112,"sex":645,"minAge":18,"maxAge":646,"enrollmentInfo":647,"targetDuration":649,"studyType":117,"phases":4,"briefSummary":650,"conditions":651,"keywords":654,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":138},"100629829","biomarker-research-on-ultra-high-field-mri-combined-with-visual-perception-assessment-in-the-diagnosis-and-treatment-outcomes-of-severe-mental-disorders-100629829","NCT07479758","Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders","Inclusion Criteria:\n\n* Participants aged 18 to 45 years old at the time of enrollment\n* Male or female participants\n* For patients: A diagnosis of major depressive disorder (MDD), schizophrenia (SZ), or bipolar disorder (BD) based on DSM-5 criteria\n* For healthy controls: No history of any mental health disorders\n* No current severe medical illnesses or history of brain injury such as encephalitis\n* Ability to provide written informed consent by the participant or their guardian\n\nExclusion Criteria:\n\n* History of head injury or brain diseases such as epilepsy\n* Presence of severe physical illnesses such as tumors or thyroid problems\n* Presence of metal implants in the body like pacemakers or brain devices\n* Fear of enclosed spaces (claustrophobia) or inability to undergo an MRI scan\n* Current pregnancy","FEMALE","45 Years",{"count":648,"type":22},320,"4 Weeks","This is an observational study aiming to screen biomarkers associated with the diagnosis and treatment outcomes of severe mental disorders (MDD\u002Fmajor depressive disorder, SZ\u002Fschizophrenia, BD\u002Fbipolar disorder) through 7T ultra-high-field magnetic resonance multimodal imaging and visual perception assessment, thereby optimizing the objectivity and precision of clinical diagnosis and treatment.\n\nI. Core Research Objectives\n\n1. Clarify the specific changes in visual perception behavior and brain imaging (metabolism, functional connectivity) of patients with severe mental disorders before and after treatment.\n2. Establish a biomarker system related to disease diagnosis and treatment outcomes to make up for the limitation of current clinical reliance on phenomenological diagnosis.\n\nII. Study Subjects and Inclusion\u002FExclusion Criteria\n\n1. Recruitment Scope\n\n   * Patient group: MDD, SZ, and BD patients diagnosed in the Department of Psychiatry, the Second Affiliated Hospital of Zhejiang University School of Medicine.\n   * Healthy control group: Healthy individuals without a history of mental illness recruited from the general population.\n2. Key Criteria\n\n   * Inclusion: Aged 18-45 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria (for the patient group); no organic brain injury or severe physical illness; signing the informed consent form.\n   * Exclusion: Organic brain diseases; severe physical illnesses (e.g., tumors); internal metal implants (e.g., cardiac pacemakers); claustrophobia or inability to tolerate MR examinations; pregnancy, etc.\n\nIII. Core Study Procedures\n\n1. All participants will undergo 2 sessions of 7T MRI scans (including MRS, fMRI, and other multimodal sequences), focusing on the MT+ brain region and V1 brain region respectively, with the scan order randomly balanced.\n2. During the interval between the two MRI scans, participants will complete visual psychophysical experiments, cognitive function tests (e.g., BDT test), and clinical symptom collection.\n3. The study will not interfere with routine clinical treatment and strictly adheres to the ethical standards of the Second Affiliated Hospital of Zhejiang University School of Medicine (Ethical Approval No.: 2025 Lun Shen Yan Di 0603).\n\nIV. Study Significance\n\n1. Provide objective biomarkers for clinical practice to improve the accuracy of diagnosis and the scientificity of treatment effect evaluation for severe mental disorders.\n2. Reveal the association mechanism between visual cortex-related brain networks and diseases, laying a theoretical foundation for precision diagnosis and treatment.",[652,56,28,653],"Major Depressive Disorder (MDD)","Severe Mental Disorders",[655,656,657,658],"Ultra-High-Field MRI","Visual Perception","Magnetic Resonance Spectroscopy","Mental Health Biomarkers","2026-04-26",{"date":661,"type":33},"2026-04-28",{"date":663,"type":33},"2025-11-01",{"date":665,"type":22},"2027-06-30",{"name":667,"class":69},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]