[{"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":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,92,0,25,[9,49,77,105,136,166,189,215,243,273,296,318,343,370,399,424,448,473,499,531,550,576,596,625,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053742","the-effect-of-comorbid-alcoholsubstance-use-100053742",false,"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.","ALL","18 Years","65 Years",{"count":21,"type":22},297,"ESTIMATED","OBSERVATIONAL","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.",[26,27,28,29,30,31,32],"Alcohol Abuse","Alcohol Use Disorder","Substance Use Disorders","Severe Mental Disorder","Schizophrenia","Bipolar Disorder","Ostracism",[34,28,29,35],"alcohol use disorder","ostracism","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2026-06-20",{"date":44,"type":22},"2026-12-30",{"name":46,"class":47},"Abant Izzet Baysal University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"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":57,"type":22},100,"INTERVENTIONAL",[60],"NA","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.",[31],[64,65,66],"ketogenic","long-acting injectable","rural","NOT_YET_RECRUITING","2026-06-30",{"date":70,"type":40},"2026-07-02",{"date":72,"type":22},"2026-08",{"date":74,"type":22},"2026-12",{"name":76,"class":47},"University of Alabama at Birmingham",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"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":85,"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.",[88,89,90,31],"Behavioral Variant of Frontotemporal Disorder (bvFTD)","Phenocopy Frontotemporal Dementia (phFTD)","Frontal Variant of Alzheimer Disease",[92,93,94,95],"bvFTD","fvAD","phFTD","bipolar disorder,personality","2026-06-25",{"date":98,"type":40},"2026-06-29",{"date":100,"type":40},"2023-12-14",{"date":102,"type":22},"2026-12-14",{"name":104,"class":47},"Nantes University Hospital",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":4,"leadSponsor":133,"locationsCount":48},"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).",true,"3 Years","99 Years",{"count":116,"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.",[119,120,121,31,122],"Mood Disorders","Anxiety Disorders","Healthy Volunteers","Depression",[124,125,126,127,128],"Screening","Anxiety","Mood","Diagnostic Testing","Natural History","2026-06-24",{"date":96,"type":40},{"date":132,"type":40},"2001-02-02",{"name":134,"class":135},"National Institute of Mental Health (NIMH)","NIH",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":143,"targetDuration":4,"studyType":58,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":165},"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":144,"type":22},424,[146],"PHASE3","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.",[149,31],"Mania",[151,149,152,153,154],"Bipolar-I Disorder","KarXT","adjunctive treatment","mood stabilizer","2026-06-22",{"date":157,"type":40},"2026-06-23",{"date":159,"type":40},"2025-10-08",{"date":161,"type":22},"2027-06-28",{"name":163,"class":164},"Bristol-Myers Squibb","INDUSTRY",104,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":58,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100614944","phase-2-a-study-of-brenipatide-in-adult-participants-with-bipolar-disorder-renew-bipolar-1-100614944","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","75 Years",{"count":175,"type":22},400,[177],"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.",[31],"2026-06-19",{"date":157,"type":40},{"date":183,"type":40},"2025-11-24",{"date":185,"type":22},"2027-11",{"name":187,"class":164},"Eli Lilly and Company",87,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":112,"sex":17,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":48},"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).","8 Years","70 Years",{"count":198,"type":22},1260,"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.",[31,201,202],"Major Depression","Migraine",[119,204,205,206,207,128],"Actigraphy","CIRCADIAN RHYTHMS","Sleep","Ecological Momentary Assessments","2026-06-18",{"date":155,"type":40},{"date":211,"type":40},"2023-11-03",{"date":213,"type":22},"2026-07-31",{"name":134,"class":135},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":58,"phases":224,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"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":223,"type":22},50,[225],"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.",[30,228,31,229,230],"Schizoaffective Disorder","Major Depressive Disorder","Tardive Dyskinesia",[232],"Valbenazine","2026-06-15",{"date":235,"type":40},"2026-06-16",{"date":237,"type":40},"2025-08-29",{"date":239,"type":22},"2027-01",{"name":241,"class":164},"Neurocrine Biosciences",22,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":58,"phases":253,"briefSummary":254,"conditions":255,"keywords":259,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"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":175,"type":22},[146],"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).",[31,256,257,258],"Bipolar Depression","Bipolar I Disorder","Bipolar II Disorder",[260,261,262],"Bipolar","XEN1101","Azetukalner","2026-06-01",{"date":265,"type":40},"2026-06-03",{"date":267,"type":40},"2025-08-08",{"date":269,"type":22},"2028-08",{"name":271,"class":164},"Xenon Pharmaceuticals Inc.",28,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":58,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":48},"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":57,"type":22},[60],"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.",[285,122,31,286],"Anxiety Disorders and Symptoms","Symptoms","2026-05-19",{"date":289,"type":40},"2026-05-22",{"date":291,"type":40},"2024-08-02",{"date":293,"type":22},"2027-07",{"name":295,"class":47},"Weill Medical College of Cornell University",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":112,"sex":17,"minAge":304,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":58,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"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":306,"type":22},1100,[60],"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.",[31,30],{"date":289,"type":40},{"date":312,"type":40},"2014-11-07",{"date":314,"type":22},"2028-11",{"name":316,"class":47},"Pr. Marion Leboyer",6,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":58,"phases":326,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":341,"locationsCount":48},"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.","60 Years",{"count":223,"type":22},[177],"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.",[31,329],"Delayed Sleep-Wake Phase Disorder",[331,332,333,334],"Correcting Circadian Rhythms","Melatonin","Placebo","Dim light melatonin onset","2026-05-07",{"date":337,"type":40},"2026-05-11",{"date":339,"type":40},"2024-08-13",{"date":74,"type":22},{"name":342,"class":47},"Leslie Swanson",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":349,"maxAge":19,"enrollmentInfo":350,"targetDuration":4,"studyType":58,"phases":352,"briefSummary":353,"conditions":354,"keywords":358,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":48},"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":351,"type":22},30,[177],"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).",[355,229,31,356,357],"Depressive Disorder","Post Traumatic Stress Disorder","Suicidal Ideation",[359,360],"Ketamine","Suicide","2026-05-05",{"date":363,"type":40},"2026-05-06",{"date":365,"type":40},"2023-04-03",{"date":367,"type":22},"2033-03",{"name":369,"class":47},"Yale University",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":112,"sex":376,"minAge":18,"maxAge":377,"enrollmentInfo":378,"targetDuration":380,"studyType":23,"phases":4,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":48},"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":379,"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.",[383,30,31,384],"Major Depressive Disorder (MDD)","Severe Mental Disorders",[386,387,388,389],"Ultra-High-Field MRI","Visual Perception","Magnetic Resonance Spectroscopy","Mental Health Biomarkers","2026-04-26",{"date":392,"type":40},"2026-04-28",{"date":394,"type":40},"2025-11-01",{"date":396,"type":22},"2027-06-30",{"name":398,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":48},"100585077","identifying-cerebral-hemodynamic-patterns-in-mood-disorders-and-mild-cognitive-impairment-a-functional-near-infrared-spectroscopy-fnirs-study-100585077","NCT06897670","Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study","Inclusion Criteria\n\nGeneral Inclusion Criteria (across all diagnostic groups):\n\n* 18 years and older\n* Ability to provide written informed consent\n* Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures\n* Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI)\n* Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention\n\nSpecific Inclusion Criteria (for diagnostic groups):\n\n* Healthy control\n\n  o No past or current psychiatric or cognitive disorder\n* Major depressive disorder (MDD):\n\n  * Diagnosis of major depressive disorder, confirmed through clinical evaluation.\n  * No history of bipolar disorder or psychotic symptoms.\n* Bipolar disorder:\n\n  o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.\n* Mild Cognitive Impairment (MCI):\n\n  * Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and\u002For MRI, PET scan data.\n  * No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia.\n\nExclusion Criteria\n\nGeneral Exclusion Criteria (across all diagnostic groups):\n\n* Active primary psychotic or substance use disorders (except nicotine dependence) within the past year\n* Any severe or unstable medical condition that could interfere with participation or data collection\n* Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results\n* Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol\n* Pregnant women will be excluded due to potential physiological changes that could affect study outcomes\n\nSpecific Exclusion Criteria (for diagnostic groups):\n\n* Healthy control\n\n  o Any past or current psychiatric or cognitive disorder\n* Major depressive disorder (MDD):\n\n  * Diagnosis of bipolar disorder or schizophrenia.\n  * Brain stimulation therapy within the past 3 months.\n* Bipolar disorder:\n\n  o Diagnosis of schizophrenia or schizoaffective disorder.\n* Mild Cognitive Impairment (MCI):\n\n  * Diagnosis of dementia.\n  * Significant cognitive impairment preventing understanding or completion of study tasks.",{"count":406,"type":22},200,"The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.",[229,31,409],"Mild Cognitive Impairment",[411,412,413,414],"functional near-infrared spectroscopy","diagnostics","mood disorders","mild cognitive impairment","2026-04-24",{"date":417,"type":40},"2026-04-29",{"date":419,"type":40},"2025-03-26",{"date":421,"type":22},"2028-03-30",{"name":423,"class":47},"Mayo Clinic",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":58,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":48},"100635759","a-study-of-senyo-health-with-comorbid-alcohol-use-disorder-treatment-in-bipolar-patients-100635759","NCT07556861","A Study Of Senyo Health With Comorbid Alcohol Use Disorder Treatment In Bipolar Patients","Senyo Health App - Comorbid Substance Use Disorder Treatment In Bipolar Patients Using A Telehealth Collaborative Care Platform","Inclusion Criteria:\n\n* History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type\n* Alcohol use disorder.\n* Ability to read, write, and understand English;\n* Minimum DAST (1+) or AUDIT-C score (3+)\n* Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care;\n* Eligibility determined by ASAM Assessment\n\nExclusion Criteria:\n\n* Diagnosed personality pathology as the primary presenting concern based on clinical judgment, severe cognitive impairment (e.g., intellectual disability or dementia), or psychosis;\n* Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment;\n* Needing a higher level of mental health care as demonstrated by ASAM\\[36\\] assessment;\n* Decline to answer suicidality questions;\n* Already admitted into or about to initiate treatment in another addiction treatment program.\n* Currently attending High School.\n* Pregnancy confirmed by self-report",{"count":432,"type":22},40,[60],"The purpose of this study is to examine the effectiveness of a digital integrated behavioral health (IBH) platform in improving substance use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder.",[31,436],"Substance Use (Drugs, Alcohol)",[260,438,439,440],"Substance Use","SUD","Alcohol","2026-04-22",{"date":417,"type":40},{"date":444,"type":22},"2026-05-16",{"date":446,"type":22},"2029-01-20",{"name":423,"class":47},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":48},"100531815","mhealth-estimate-based-algorithms-signaling-upcoming-recurrence-of-episodes-in-bipolar-disorders-100531815","NCT06204705","mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders","mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders (MEASURE-BD)","MEASURE-BD","Inclusion Criteria:\n\n* Veteran participants will have a confirmed primary diagnosis of a Bipolar I Disorder, Bipolar II Disorder or Other Specified Bipolar Disorder (i.e., those with major depressive episodes and hypomania that meets all episode criteria but for duration) based on the clinical Interview for DSM-5-Research Version (SCID-5-RV), medical chart review and consensus procedure directed by the PI\n* All Veteran participants will endorse presence of at least one bipolar episode in the last 12 months based on the interview and\u002For medical chart information\n* All Veteran participants will own a smartphone capable of running all study apps\n* All participants will be age 18 years or older\n* All participants will be fluent in English\n* All Veteran participants will be able to demonstrate capacity for consent (see below) and have no active court-appointed legal guardianship precluding ability to provide consent\n* Focus group participants will be active Minneapolis VAHCS providers and administrators who are either actively engaged in care for Veterans with BD or involved in administrative roles overseeing mental health care of Veterans within Minneapolis VAHCS\n\nExclusion Criteria:\n\n* Presence of a major neurocognitive disorder or neurological disorder, such as Alzheimer's dementia, vascular dementia, Parkinson's disease, etc.\n* Impaired global cognition (MoCA score \\\u003C 20 for in-person assessment, or equivalent score on \"blind\" MoCA for virtual assessments)\n* Presence of physical conditions preventing use of smartphone apps Lack of capacity to provide informed consent\n* Age \\\u003C 18 years\n* No exclusion for focus group participants as their VA status employment will be taken to indicate age of majority, intact global cognition, etc.",{"count":406,"type":22},"Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning.\n\nObjective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS\u002Flocation. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The goal of this Merit Review proposal is to establish reliable and valid machine-learning algorithms using the same types of mHealth data to prospectively (days in advance) detect declines in social participation and prospective onset of mania and depression in Veterans with BD. This proposal has three aims:\n\nAim 1. To establish a machine learning algorithm using GPS\u002Flocation data for predicting prospective declines in social participation in Veterans with BD.\n\nAim 2. To establish machine learning algorithms using GPS\u002Flocation data for predicting prospective acute BD clinical states. The investigators will explore whether adding more burdensome daily self-report and voice diaries' speech analysis features improves the models' precision using statistical indices of prediction precision or accuracy.\n\nAim 3. To explore clinical implementation of the mHealth-based algorithms in treatment of BD. Focus groups of VA providers and administrators will assess feasibility of algorithms' implementation in clinical care.",[31],[31,460,461,462,463],"Veterans","Telemedicine","Digital Phenotyping","Machine Learning","2026-04-21",{"date":415,"type":40},{"date":467,"type":40},"2024-09-10",{"date":469,"type":22},"2027-09-30",{"name":471,"class":472},"VA Office of Research and Development","FED",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":480,"targetDuration":4,"studyType":58,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":48},"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":481,"type":22},20,[60],"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.",[229,31,30],[486,487,488,489,490,491],"Electroconvulsive Therapy","Isolated Forearm Technique","Sugammadex","Neuromuscular Blockade","Seizure Monitoring","Tourniquet","2026-04-16",{"date":464,"type":40},{"date":495,"type":22},"2026-04-20",{"date":42,"type":22},{"name":498,"class":47},"Medipol University",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":58,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"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 PRRC, MHICM and\u002For 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 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 age 18 or above\n4. Be fluent and literate in English.\n5. 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":508,"type":22},119,[60],"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.",[30,228,512,31,229],"Delusional Disorder",[514,515,516,517,518,519,520,521],"serious mental illness","psychosis","collaborative decision-making","shared decision-making","veterans","recovery","personal recovery","empowerment","2026-04-14",{"date":524,"type":40},"2026-04-15",{"date":526,"type":22},"2026-07-01",{"date":528,"type":22},"2029-09-30",{"name":471,"class":472},3,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":377,"enrollmentInfo":537,"targetDuration":4,"studyType":58,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":530},"100544755","use-of-ketosis-in-modulating-metabolic-pathways-in-bipolar-disorder-100544755","NCT06373016","Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder","Inclusion\u002FExclusion Criteria:\n\n* Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)\n* Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks\n* Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls\n* Weight does not exceed 350lbs.\n* Diameter does not exceed 60 cm when supine\n* HbA1C \\\u003C 7%\n* No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)\n* No claustrophobia\n* No history of significant head injury\n* No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months\n* No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation\n* Are not deemed a serious suicide or homicide risk\n* No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease\n* No seizure disorders\n* Have the capacity to sign informed consent\n* No current diagnosis or history of an alcohol or substance use disorder in the last 6 months or positive test for an illicit drug on the screening urine analysis (positive cannabis screen is not exclusionary): confirmed using urine toxicology test during the initial screening visit and before each MRI scan visit.\n* For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease\n* Must have vision that is 20\u002F20 or correctable to 20\u002F20 with contact lenses\n* No Type 1 diabetes mellitus\n* No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others.\n* No kidney disease, as determined by medical history and\u002For blood work\n* No history of heart attack or stroke\n* No difficulty swallowing\n* No myxedema\n* No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test\n* No breastfeeding",{"count":57,"type":22},[60],"The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior.",[31,541],"Bipolar Disorder Type 1","2026-04-10",{"date":524,"type":40},{"date":545,"type":40},"2024-01-26",{"date":547,"type":22},"2027-02-01",{"name":549,"class":47},"Stony Brook University",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":558,"targetDuration":4,"studyType":58,"phases":559,"briefSummary":560,"conditions":561,"keywords":562,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":48},"100631637","functional-magnetic-resonance-imaging-study-of-inhibitory-control-in-bipolar-disorder-and-major-depressive-disorder-100631637","NCT07503275","Functional Magnetic Resonance Imaging Study of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder","Neurofunctional Characterization of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder","COLIBRI","Group 1 and 2: Bipolar patients, Depressive patients\n\nInclusion criteria:\n\n* Patients between 18 and 65 years old, men or women, right-handed\n* Having a diagnosis of bipolar disorder or depressive disorder\n* No substantial change in treatment for 2 weeks preceding study enrollment\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* A significant general medical illness, including neurological disorders or head trauma\n* Contraindication to the use of MRI\n* A sensorial impairment uncorrected (visual and\u002For hearing)\n\nGroup 3 and 4: Healthy control participants\n\nInclusion criteria:\n\n* Participants between 18 and 65 years old, men or women, right-handed\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* A diagnosis of schizophrenia or of bipolar disorder or of major depressive disorder according to DSM-5 criteria\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* Participants having one first-degree relative presenting an bipolar disorder or depressive disorder or schizophrenia according to DSM-5 criteria\n* A significant general medical illness, including neurological disorders or head trauma\n* Contraindication to the use of MRI\n* A sensorial impairment uncorrected (visual and\u002For hearing)",{"count":85,"type":22},[60],"Bipolar disorder and unipolar depressive disorder are two chronic mood disorders associated with a significant social impact, even during euthymic phases. Their differential diagnosis remains complex, particularly when bipolar disorder begins with a depressive episode. Identifying distinctive markers between these pathologies therefore represents a major clinical and economic challenge, as appropriate mood-stabilizing treatment can reduce healthcare costs and improve patients' functional outcomes.\n\nAmong potential biomarkers, executive functions-and more specifically inhibition-have received particular attention. Inhibitory deficits are observed in both disorders, including during euthymic states, and also among first-degree relatives, suggesting their potential as cognitive and cerebral endophenotypes. These deficits may help explain the difficulties in emotion regulation and impulsivity frequently observed in mood disorders.\n\nTwo components of inhibition are distinguished:\n\n1. Behavioral inhibition, which refers to the ability to stop an ongoing response.\n2. Interference control, which refers to the ability to resist distraction. These processes rely on partially distinct neural networks and operate at different stages of information processing. The few studies comparing these two components in bipolar disorder have shown contradictory results, and neuroimaging investigations have only partially explored these mechanisms, particularly their emotional dimension. It is, however, well established that patients with bipolar or depressive disorders show greater difficulties in executive tasks involving emotional stimuli than in purely cognitive tasks.\n\nThe study is expected to reveal:\n\n* Differences in brain activation between euthymic bipolar and unipolar depressive patients in regions involved in inhibitory control, modulated by the emotional content of the task.\n* Distinct cognitive performance profiles according to pathology, reflecting specific alterations in inhibitory and interference processes.\n\nThese findings should provide a better understanding of the differential neurocognitive bases of mood disorders. Identifying specific cognitive and neural profiles could contribute to more accurate differential diagnosis and to the personalization of therapeutic interventions, particularly through cognitive remediation strategies targeting executive and emotional deficits.",[31,229],[563,564,565,566],"fMRI","bipolar disorder","major depressive disorder","inhibitory control","2026-03-25",{"date":569,"type":40},"2026-03-31",{"date":571,"type":22},"2026-06",{"date":573,"type":22},"2029-12",{"name":575,"class":47},"CHU de Reims",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":582,"targetDuration":4,"studyType":58,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":48},"100474404","phase-2-assessing-the-impact-of-cannabidiol-for-anxiety-and-depression-in-bipolar-disorder-100474404","NCT05457465","Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder","Inclusion Criteria:\n\n* Provides informed consent\n* Between the ages of 18-65\n* Fluent in English\n* Meets DSM-5 criteria for bipolar disorder (type I or II)\n* Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)\n* On a stable pharmacotherapeutic regimen\n\nExclusion Criteria:\n\n* Not fluent in English\n* Estimated IQ \\\u003C75\n* Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)\n* Endorsement of suicidality\n* Experiencing acute manic episode\n* Experiencing acute depressive episode\n* History of head injury\u002Floss of consciousness \\>5 minutes\n* Current regular use of cannabinoid products\n* Pregnant or breastfeeding\n* Presence of serious medical illness or neurological disorder\n* Allergy to palm oil\n* Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis\n* Currently enrolled in another clinical trial that involves a treatment\n* Elevated LFTs at screening visit",{"count":7,"type":22},[177],"Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.",[31],[587],"Cannabidiol","2026-03-24",{"date":590,"type":40},"2026-03-30",{"date":592,"type":40},"2023-06-01",{"date":74,"type":22},{"name":595,"class":47},"Mclean Hospital",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":603,"targetDuration":4,"studyType":58,"phases":605,"briefSummary":606,"conditions":607,"keywords":610,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100544599","theta-burst-stimulation-for-bipolar-depression-100544599","NCT06370988","Theta-Burst Stimulation for Bipolar Depression","TRIBE","Inclusion Criteria\n\nThe participant must meet all of the inclusion criteria to eligible for this clinical trial:\n\n1. Must be deemed to have capacity to provide informed consent;\n2. Must be an outpatient\n3. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI);\n4. Age 18-65;\n5. failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43\n6. moderately severe depression with a score ≥ 15 on the PHQ-9;44\n7. not currently experiencing a mixed or manic episode (YMRS ≤10);\n8. no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \\[3-6mg\\], low-dose benzodiazepines \\[≤2mg lorazepam daily equivalent\\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;\n9. able to adhere to the treatment schedule;\n10. pass the TMS adult safety screening questionnaire.45\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this clinical trial:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and\u002For caffeine) within the last 3 months;\n2. have a concomitant major unstable medical illness;\n3. have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);\n4. are pregnant or intend to get pregnant during the study;\n5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;\n6. have psychotic symptoms within the current episode;\n7. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and\u002For causing greater impairment than BD-DE;\n8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;\n9. have received any rTMS before due to potential to compromise blinding of treatment allocation;\n10. have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);\n11. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n12. are participating in psychotherapy for less than 3 months. Patients will be permitted if they have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;\n13. are currently taking lorazepam \\>2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;\n14. are currently taking any dose of an anticonvulsant due to the potential to limit rTMS efficacy. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;\n15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).",{"count":604,"type":22},124,[60],"The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.",[256,31,608,609],"Treatment- Resistant Bipolar Disorder","Type 2 Bipolar Disorder",[611,612,613,614],"Transcranial Magnetic Stimulation","Repetitive Transcranial Magnetic Stimulation","rTMS","iTBS","2026-03-16",{"date":617,"type":40},"2026-03-18",{"date":619,"type":40},"2024-05-15",{"date":621,"type":22},"2029-05",{"name":623,"class":47},"Centre for Addiction and Mental Health",2,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":58,"phases":634,"briefSummary":635,"conditions":636,"keywords":639,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":48},"100302436","cerebellar-stimulation-and-cognitive-control-100302436","NCT03217110","Cerebellar Stimulation and Cognitive Control","Cerebellar Transcranial Magnetic Stimulation and Cognitive Control","Inclusion Criteria:\n\n* A clinical diagnosis consistent with enrollment\n\nExclusion Criteria:\n\n* History of recurrent seizures or epilepsy\n* Any other neurological or psychiatric diagnosis outside the diagnosis for which the participant is enrolled.\n* Active substance use disorder in the past 6 months other than tobacco use disorder.\n* Inability to consent for study.\n* Pacemaker\n* Coronary Stent\n* Defibrillator\n* Neurostimulation\n* Claustrophobia\n* Uncontrolled high blood pressure\n* Atrial fibrillation\n* Significant heart disease\n* Hemodynamic instability\n* Kidney disease\n* Pregnant, trying to become pregnant, or breast feeding","90 Years",{"count":406,"type":22},[60],"The purpose of this study is to examine whether cerebellar stimulation can be used to improve cognitive deficits and mood in patients with schizophrenia, autism, bipolar disorder, Parkinson's disease, and major depression.",[30,637,31,122,638],"Autism Spectrum Disorder","Parkinson Disease",[640],"Cerebellum",{"date":642,"type":40},"2026-03-19",{"date":644,"type":40},"2017-11-30",{"date":646,"type":22},"2028-12-01",{"name":648,"class":47},"Krystal Parker, PhD",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":657,"targetDuration":4,"studyType":58,"phases":658,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":671,"locationsCount":48},"100629303","empagliflozin-adjunctive-therapy-in-bipolar-depression-100629303","NCT07472920","Empagliflozin Adjunctive Therapy in Bipolar Depression","Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)","EMPA-BD","Inclusion Criteria:\n\n1. Adults aged 18 to 65 years.\n2. Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview.\n3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening.\n4. Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks.\n5. Ability to provide informed consent.\n6. Insulin resistance, defined as HOMA-IR ≥ 1.8.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.\n2. Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.\n3. Known pancreatic disease (pancreatitis or pancreatic surgery).\n4. Chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n5. Recurrent genital fungal infections.\n6. Pregnant or breastfeeding.\n7. Alcohol abuse or dependence within the past 12 months.\n8. YMRS score ≥ 12 (presence of manic or hypomanic symptoms).",{"count":481,"type":22},[60],"Bipolar disorder is a long-term mental health condition that causes mood changes, with depressive episodes being the most frequent and disabling. Many people do not fully recover with current treatments, showing the need for new therapeutic options.\n\nRecent research shows that insulin resistance (IR), a condition in which the body does not respond well to insulin, is common in people with bipolar disorder. It is linked to more severe mood symptoms, poorer treatment response, and higher risk of heart disease. IR may raise inflammation and affect how the brain uses energy, which can influence mood regulation.\n\nEmpagliflozin is a medicine approved for type 2 diabetes. In addition to its metabolic and heart benefits, studies suggest that it may also protect the brain and reduce inflammation, possibly helping to improve mood.\n\nThis open-label, proof-of-concept clinical trial will test how well empagliflozin works and how safe it is as an add-on treatment for people with bipolar depression and insulin resistance. A total of 20 adults with bipolar disorder type I or II, currently in a depressive episode, will take part in the study over a 12-week period.\n\nThe main goal is to see whether empagliflozin can lower depressive symptoms, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Other measures include changes in insulin resistance and incidence of adverse events.\n\nThe study aims to explore whether improving insulin resistance can help both mood and metabolic health in people with bipolar disorder, guiding future clinical research.",[31,256,661],"Insulin Resistance",[31,256,661,663,664,665],"Empagliflozin","SGLT2 Inhibitors","Metabolic Psychiatry","2026-03-11",{"date":615,"type":40},{"date":669,"type":22},"2026-03-09",{"date":74,"type":22},{"name":672,"class":47},"University of Sao Paulo"]