[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-ii-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-ii-disorder":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,49,77,102,126,176,202,237,268,292],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100606204","phase-3-a-randomized-study-of-azetukalner-versus-placebo-in-depressive-episodes-associated-with-bipolar-i-or-ii-disorder-bipolar-depression-100606204",false,"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.","ALL","18 Years","74 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).",[28,29,30,31],"Bipolar Disorder","Bipolar Depression","Bipolar I Disorder","Bipolar II Disorder",[33,34,35],"Bipolar","XEN1101","Azetukalner","RECRUITING","2026-06-01",{"date":39,"type":40},"2026-06-03","ACTUAL",{"date":42,"type":40},"2025-08-08",{"date":44,"type":22},"2028-08",{"name":46,"class":47},"Xenon Pharmaceuticals Inc.","INDUSTRY",28,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100569631","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-oral-icalcaprant-in-adult-participants-with-bipolar-i-or-ii-disorder-100569631","NCT06696755","A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder","A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression","Inclusion Criteria:\n\n* Participants with a diagnosis of bipolar I or II according to the (Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0.2, and currently experiencing an (major depressive episode) MDE beginning at least 4 weeks prior to consent and not exceeding 6 months prior to screening.\n* Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg\u002Fm\\^2.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n* CGI-S-BP score of ≥ 4 for depression and overall bipolar illness at screening (Visit 1) and baseline (Visit 2).\n* YMRS total score ≤ 12 at screening (Visit 1) and baseline (Visit 2).\n* Participants on treatment with a single mood stabilizer (lithium, valproate, or lamotrigine), maintained at a stable dose for ≥ 28 days prior to screening. Current mood stabilizer dose must remain unchanged for the duration of the study.\n\n  * If taking lithium or valproate, participant must have a therapeutic blood level at screening of lithium (0.8 - 1.2 mg\u002FdL) or valproate (50 - 125 mg\u002FdL).\n  * If taking lamotrigine, participant must be taking a locally approved maintenance dose.\n\nExclusion Criteria:\n\n* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and\u002For other products in the same class.\n* History of or active medical conditions(s) that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal, hepatic, gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with the participant's participation in the study, the participant may be included in the study).","65 Years",{"count":58,"type":22},195,[60],"PHASE2","Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder.\n\nIcalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to a placebo. Around 195 adult participants with bipolar I or II disorder will be enrolled in approximately 35 sites across the United States of America.\n\nParticipants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period.\n\nThere may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[30,31],[30,31,28,64,65,66],"lcalcaprant","ABBV-1354","CVL-354","2026-05-11",{"date":69,"type":40},"2026-05-13",{"date":71,"type":40},"2026-02-03",{"date":73,"type":22},"2027-11",{"name":75,"class":47},"AbbVie",31,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100559194","synced---synchronized-eating-in-bipolar-depression-study-100559194","NCT06560957","SYNCED - SYNChronized Eating in Bipolar Depression Study","Feasibility and Acceptability of Adjunctive Time Restricted Eating in Bipolar Disorder: A Pilot Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Be 18-55 years old\n2. Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.\n3. Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS.\n4. Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\\*\n5. Participants must be able to speak, read, write and understand English or French.\n6. Be willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.\n2. Have any unstable or inadequately treated neurological and medical conditions.\n3. Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications.\n\n5\\. Be pregnant or lactating. 6. Currently taking any stimulant medications. 7. Be participating in any other diet or weight management program for the duration of the trial.\n\n8\\. Have any contraindication to fasting as judged by the assessing clinician. 9. Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).\n\n10\\. Have any other medical condition, substance use disorder or suicidal ideation for which physician or investigator team expresses concern about safety or ability to participate in the study.","55 Years",{"count":86,"type":22},40,[88],"NA","Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment. Circadian rhythm (your internal day\u002Fnight \"clock\") disruption, which can involve changes in sleep-wake cycles, frequently occurs in BD. Both depression and mania are accompanied by circadian disruption. These disruptions are hypothesized to lead to mood worsening, metabolic dysfunction and inflammation. If circadian dysfunction plays a significant role in the symptoms and trajectory of BD, then treatment approaches that target these functions may lead to better outcomes. One such approach is dietary interventions. Time restricted eating (TRE) is a dietary tool that restricts the eating to an 8-12 hour window, without changing diet quality or caloric intake. Studies involving time restricted eating have been done in other conditions with promising results. There have been no studies done for mood disorders in general or bipolar disorder specifically. In this proposal, the investigators will assess two dietary interventions (TRE and nutritional counselling) to examine how TRE may represent a safe and viable adjunct to traditional treatments. The investigators aim to compare TRE with nutritional counselling, while all participants continue to receive usual care. Participants will receive support from a registered dietician and will be instructed on dietary habits. Half of participants will receive nutritional counselling and half will be asked to do TRE. Those in the TRE group will be asked to select a 10-hour window to consume all food and non-water beverages for the 8-week period. Participants will be asked to complete a screening visit to determine eligibility, and then will complete questionnaires at baseline, week 4 and week 8 examining symptoms of their illness and cognition. Participants will also provide a blood sample at baseline and week 8 for standard biochemistry tests, pregnancy testing (if applicable), and to examine inflammatory markers. Participants will also wear an actigraphy watch which provides wireless continuous monitoring of movements and ambient light. The primary outcome is feasibility and acceptability (do people agree to participate, complete the study, and follow the intervention; what do they think of the intervention). Secondary outcomes include changes in depression, anxiety, sleep, and cognition. Exploratory outcomes include inflammatory markers and circadian disruption.",[29,30,31],"2026-04-27",{"date":93,"type":40},"2026-05-01",{"date":95,"type":40},"2025-07-10",{"date":97,"type":22},"2027-02-26",{"name":99,"class":100},"University of Ottawa","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":101},"100530269","phase-4-lithium-versus-lamotrigine-in-bipolar-disorder-type-ii-100530269","NCT06184581","Lithium Versus Lamotrigine in Bipolar Disorder, Type II","Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)","LiLa-Bipolar","Inclusion Criteria:\n\n* Bipolar disorder, type II with diagnosis confirmed by SCAN interview\n* Age 18-70 years\n* Habile (i.e., able to give informed consent)\n\nExclusion Criteria:\n\n* Past non-response or intolerance to lamotrigine or lithium with \\> 6 weeks treatment at an adequate dosage\n* Currently taking mood stabilizers at enrollment in CADIC\n* Severe chronic kidney disease\n* Severe cardiac insufficiency\n* Brugadas syndrome\n* Severe hypothyroidism despite treatment\n* Women who are pregnant, breastfeeding or planning pregnancy in near future.","70 Years",{"count":112,"type":22},200,[114],"PHASE4","The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.",[31],"2026-03-17",{"date":119,"type":40},"2026-03-20",{"date":121,"type":40},"2024-05-08",{"date":123,"type":22},"2027-12-01",{"name":125,"class":100},"University Hospital Bispebjerg and Frederiksberg",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":160,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":101},"100577917","lhc-cidi-5-in-hong-kong-100577917","NCT06804525","LHC-CIDI-5 in Hong Kong","Use of Life History Calendars to Enhance Measurement of Lifetime Experience With Mental Disorders in Hong Kong.","Inclusion Criteria:\n\n* All household members aged 25 years old and over are randomly sampled from the Census and Statistics Department List of Quarters\n* Live in the address sampled from the Census and Statistics Department List of Quarters\n* Reside in Hong Kong for at least six months in the past year\n* Able to read and communicate in Chinese or English\n* Without linguistic or cognitive difficulties\n\nExclusion Criteria:\n\n* Domestic workers","25 Years",{"count":135,"type":22},2500,"OBSERVATIONAL","The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders.\n\nTo mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study.\n\nIn a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation.\n\nThis experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.",[139,140,141,142,143,144,145,146,147,148,30,149,31,150,151,152,153,154,155,156,157,158,159],"Major Depressive Episode (MDE)","Major Depressive Disorder (MDD)","Persistent Depressive Disorder (PDD)","Suicidal Ideation","Suicidal Plan","Suicidal Attempt","Suicidal Gesture","Nonsuicidal Self-Injury","Manic Episode","Hypomanic","Bipolar Sub Disorder","Generalized Anxiety Disorder (GAD)","Intermittent Explosive Disorder (IED)","Panic Attack","Panic Disorder","Obsessive-Compulsive Disorder (OCD)","Posttraumatic Stress Disorder (PTSD)","PCL-SC PTSD","PCL-5 PTSD","Alcohol Use Disorder (AUD)","Substance Use Disorder (SUD)",[161,162,163,164,165,166],"Life History Calendar","CIDI","Recall bias","Retrospective reporting","Lifetime prevalence","Mental disorders","2026-03-09",{"date":169,"type":40},"2026-03-10",{"date":171,"type":40},"2025-01-18",{"date":173,"type":22},"2027-04",{"name":175,"class":100},"The University of Hong Kong",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":101},"100609352","phase-4-individualized-pharmacological-approach-to-obesity-in-patients-with-bipolar-disorder-100609352","NCT07213466","Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder","Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo","OBOE-Mayo","Inclusion Criteria:\n\n* Men or women between 18 to 65 years old.\n* Patients with a SCID IV confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type (SZA-BD).\n* Women with a negative pregnancy test 48 hours before study entry (obesity phenotyping visit).\n* Patients with a negative urine drug screen except for allowable drugs.\n* Patients with a BMI ≥ 30 kg\u002Fm2 or a BMI ≥ 27 kg\u002Fm2 plus one medical comorbidity (e.g., type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea)\n* Patients must be undergoing mood stabilizer treatment but may also receive concurrent antidepressant or anxiolytic therapy.\n* Patients must be on a stable regimen of a mood stabilizer, with no changes to the medication, for at least one month prior to study enrollment.\n* Continuation of mood-stabilizing treatment is preferred but not required; the decision should be made in collaboration with the participant's primary mental health provider.\n\nExclusion Criteria:\n\n* Abdominal bariatric surgery: Gastric bypass surgery (Roux-en-Y), Adjustable gastric band (Lap band), and Gastric sleeve surgery (Sleeve gastrectomy).\n* Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, such as diabetic gastroparesis; or use of medications that may alter gastrointestinal motility and appetite.\n* Positive history of chronic gastrointestinal diseases that could affect gastrointestinal absorption such as inflammatory bowel disease (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), etc; or use of medications that may alter gastrointestinal absorption.\n* Significant untreated psychiatric dysfunction.\n* Hypersensitivity to any of the study medications.\n* Contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Oral naltrexone extended-release\u002Fbupropion extended-release (NBSR; Contrave®, Mysimba™); and Semaglutide (Weygovy™).\n* Inability to provide informed consent: participants who are on involuntary commitment, conservatorship or under a legal guardian.\n* Patients with active hypomania or mania (YMRS ≥ 20 points)\n* Patients with active psychosis (YMRS item 8 ≥ 6 points)\n* Patients with active suicide ideation (MADRS item 10 ≥ 4 points)\n* Patients with any medication changes (mood stabilizers) without advisement of study clinicians or clinical provider.\n* Patients with active bulimia (purging) or anorexia (severe restriction)\n* Patients with a history of bulimia (purging behaviors) or anorexia (severe dietary restriction) within the 12 months preceding study enrollment will be excluded\n* Current drug and\u002For alcohol use disorders (except nicotine)\n* Patients with a positive toxicology screening (except cannabis)\n* Positive toxicology screen for cannabis and a cannabis use disorder by CUDIT-R.\n* Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.\n* Patients unwilling to complete the full phenotyping day on its current form (i.e. patients avoiding gluten meal or adhering to a vegan diet).",{"count":185,"type":22},100,[114],"The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are:\n\n* Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)?\n* Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder?\n\nParticipation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone\u002FBupropion (Contrave®), or Phentermine\u002FTopiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.",[30,31,189,190,191,192],"Schizo Affective Disorder","Obesity","Weight Loss","GLP - 1","2026-03-06",{"date":195,"type":40},"2026-03-11",{"date":197,"type":40},"2026-01-19",{"date":199,"type":22},"2029-02-01",{"name":201,"class":100},"Mayo Clinic",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100472072","childrens-bipolar-network-treatment-trial-i-100472072","NCT05427123","Children's Bipolar Network Treatment Trial I","A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder","CBN","Inclusion Criteria:\n\n* Youth 9-19 years old\n* Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening\n* Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up\n* Youth has a caregiver able to participate in ongoing basis in assessment and treatment\n* The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.\n\nExclusion Criteria:\n\n* Youth has DSM-5 diagnosis of autism spectrum disorder\n* Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos.\n* Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment\n* Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers\n* Evidence of recent intimate partner violence between caregivers responsible for the youth's care","9 Years","19 Years",{"count":213,"type":22},80,"This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reliably diagnose youth (ages 9 to 19 yrs) with full bipolar disorder (BD) and BSDs, and (2) examine predictors (e.g., mood instability, inflammatory marker C-reactive protein) of clinical outcome over a 12 month period. Participating youth will initially complete a screening that includes a structured diagnostic interview and a baseline blood draw to measure inflammatory processes. Youth with BSD and parents (80 families) will be asked to participate in multiple follow up research visits with interviews, rating instruments, and questionnaires. Per established CBN guidelines, study psychiatrists will provide and track medication management and sites will also track psychosocial treatments. This study ultimately aims to further understanding of best practice pediatric BSD psychiatric and psychosocial treatments and development of a standardized and validated set of clinical tools for patient assessment, diagnosis, and tracking.",[28,30,31,216,217,218,219],"Other Specified Bipolar and Related Disorder","Mood Instability","Child Mental Disorder","Adolescent - Emotional Problem",[221,222,223,224,225,226],"medication","psychosocial","treatment","longitudinal","naturalistic","assessment","2026-02-02",{"date":229,"type":40},"2026-02-05",{"date":231,"type":40},"2022-07-01",{"date":233,"type":22},"2027-07-01",{"name":235,"class":100},"University of California, Los Angeles",4,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":245,"maxAge":110,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":101},"100602776","closed-loop-deep-brain-stimulation-for-treatment-resistant-bipolar-depression-100602776","NCT07127913","Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression","Closed-Loop Deep Brain Stimulation for Bipolar Depression (PReSiDio-BP)","PReSiDio-BP","Inclusion Criteria:\n\n* Age 22-70\n* Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Bipolar II Disorder, with an episode of depression lasting at least 1 year that is treatment resistant as defined above, without a manic or hypomanic episode in the last 2 years; patients must be taking a mood stabilizer (lithium \\>0.6 mEq\u002FL or valproate \\>350 mM\u002FL), an atypical antipsychotic, or a combination of a mood stabilizer and an atypical antipsychotic for at least 2 weeks at a stable dosage before starting the study and must continue taking anti-manic medication throughout their participation in the study unless discontinuation is necessary because of patient safety\u002Fhealth considerations.\n* Must have either failed ECT (it was effective but not tolerated due to side effects; it was effective, but patients could not achieve a sustained response), not been able to complete a course of ECT due to side effects, or have been medically advised to receive ECT and have been unwilling or unable to obtain ECT.\n* Has MADRS score of \\> 26 at two baseline visits\n* Ability to complete repeated administrations of MDD rating scales.\n* If patient is on a regimen of psychotropic medication, no changes in this regimen should be expected during the 4 weeks prior to entry into and the duration of the study.\n* Willing and able to undergo invasive brain recording\u002Fstimulation study\n* Willing and able to attend multiple research visits and perform at-home research protocol\n* Willing and able to provide informed consent\n* Ability to speak and read English\n\nExclusion Criteria:\n\n* Meets DSM-V criteria for a psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, obsessive compulsive disorder, tic disorder, or another comorbid psychiatric disorder other than MDD or generalized anxiety disorder based on a SCID\n* Generalized anxiety disorder is the primary DSM-V disorder during the current MDD episode\n* Active suicidal ideation with intent and plan as defined by a score of 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* History of suicide attempt requiring hospitalization in previous 2 years.\n* Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, determined by the SCID\n* Has a personality disorder based on the investigator's assessment that the investigator believes will adversely impact subject compliance or safety\n* Fibromyalgia or chronic fatigue syndrome\n* Current condition requiring chronic narcotic use\n* History of traumatic brain injury, another neurological disorder, or developmental delay\n* History of seizures\n* MRI (done within one year of the first visit) with significant abnormalities\n* Previous ablative intracranial surgery or previously implanted deep brain stimulation system or any previously implanted device treatment involving brain stimulation\n* Implantable hardware not compatible with MRI or with the study\n* Major medical co-morbidities increasing the risk of surgery including severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation other than aspirin, active infection, intracranial space occupying lesion, increased intracranial pressure, cardiovascular accident within the last month, aneurysm\u002Fabnormality, retinal detachment, unstable cardiovascular disease (recent myocardial infarction, severe ischemia, severe or uncontrolled hypertension), immunocompromised state, or malignancy with \\\u003C 5 years life expectancy\n* Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. - Patients taking these medications will need to discuss the need\u002Frisk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) to discuss the risks of anticoagulation\u002Fantiaggregation therapy discontinuation\n* Coagulopathy. Patients will be excluded unless assessed and cleared by hematology\n* Allergies or known hypersensitivity to materials in the NeuroPace RNS® System (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel)\n* Subject lives alone without possibility of caregiver support post-hospital stay\n* Inability to comply with study follow-up visits","22 Years",{"count":5,"type":22},[88],"Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain.\n\nThe purpose of this study is to test a personalized approach to brain stimulation as an intervention for bipolar depression The study researchers will use a surgically implanted device to measure each individual's brain activity related to his\u002Fher depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies.\n\nThe device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat bipolar depression.",[31,250],"Bipolar II Disorder, Most Recent Episode Major Depressive",[31,252,253,254,255,256,257,258],"Depression","Treatment-resistance","Deep brain stimulation","Closed-loop","Biomarker","Responsive neurostimulation","Brain surgery","2025-08-13",{"date":261,"type":40},"2025-08-17",{"date":263,"type":40},"2025-07-16",{"date":265,"type":22},"2035-06-28",{"name":267,"class":100},"Andrew Krystal",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":133,"maxAge":110,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":101},"100570360","phase-2-acceptability--safety-of-two-sequential-doses-of-psilocybin-in-bipolar-disorder-ii-depression-and-suicidality-100570360","NCT06706232","Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality","Inclusion Criteria:\n\n* Must have completed written informed consent\n* Must be at 25 years of age or older at screening (but below age of 70)\n* Confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of BD-II using clinical records and Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders (DIAMOND)\n* Must meet criteria for suicidality according to the INQ cutoff scores: A score of at least 12 on the Perceived Burden (PB) subscale and at least a score of 36 on the Thwarted Belongingness (TB) subscale indicating substantial risk for passive suicidal ideation\n* Must meet criteria for depression according to the MADRS cutoff scores: A score of 7-34 indicating mild to moderate depression\n* Must pass medical examination (physical exam, personal\u002Ffamily medical history, including consultation with current medical provider, ECG, about 4 tablespoons blood draw, psychiatric\u002Fpsychological assessments, urine drug test)\n* Willingness to taper down mood stabilizers and other relevant medications (including but not limited to: antidepressants, antipsychotics, lithium, benzodiazepines, Monoamine oxidase inhibitors (MAOIs), Selective serotonin reuptake inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), A serotonin-norepinephrine-dopamine reuptake inhibitors (SNDRIs), Tricyclic antidepressants (TCAs), stimulants, cannabis, and other medications, supplements or therapeutics that affect serotonergic function) for the duration of the study before and during administration days (starting 5 weeks before administration), and be off medication for at least 2 weeks prior to administration\n* Willingness to stop allowed medication at least 24 h prior to administration of psilocybin as advised by study physician (e.g., benzodiazepines)\n* Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits\n\nExclusion Criteria:\n\n* Participants who do not read\u002Fspeak English\n* Active suicidal ideation with at least some intent and\u002For plan (i.e., a current score of 4 or 5 on the C-SSRS)\n* History of medically significant suicide attempt in the last 6 months\n* Current or past history of Bipolar I disorder, psychotic symptoms or psychotic disorder, (including but not limited to schizophrenia, delusional disorder, schizoaffective disorder) clinically relevant personality disorder (such as borderline, antisocial, narcissistic or paranoid personality disorder), or any serious psychiatric comorbidity considered negatively impacting participation or safety (e.g., PTSD or severe substance use or alcohol disorder) assessed by medical history and\u002For a structured clinical interview\n* Have a first or second degree relative with Bipolar I disorder or a psychotic disorder\n* Currently experiencing a hypomanic or mixed-symptom episode\n* Have a psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n* Any indication of a Personality Disorder (PD) such as but not limited to Borderline, Narcissistic, Antisocial, Paranoid, or Schizotypal PD based on Structured Clinical Interview for DSM-5 for PD and\u002For clinical judgment",{"count":5,"type":22},[60],"The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.",[31,278,279],"Depression, Bipolar","Suicidality",[281,282],"Bipolar II Depression","Psilocybin","2025-07-15",{"date":285,"type":40},"2025-07-18",{"date":287,"type":40},"2025-07-07",{"date":289,"type":22},"2027-01",{"name":291,"class":100},"The University of Texas Health Science Center, Houston",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":101},"100444199","phase-2-gabapentin-for-restoring-gabaglutamate-homeostasis-in-co-occurring-bipolar-and-cannabis-use-disorders-100444199","NCT05064319","Gabapentin for Restoring GABA\u002FGlutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders","Gabapentin for Restoring GABA\u002FGlutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study","Inclusion Criteria:\n\n1. Ages 18-65 years\n2. Meet DSM-5 criteria for moderate or severe cannabis use disorder (CUD; within the past 3 months), provide a positive urine cannabinoid screen at baseline, and identify cannabis as the primary substance of abuse\n3. Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type\n4. Able to provide informed consent and read, understand, and accurately complete assessment instruments\n5. Willing to commit to medication treatment and follow-up assessments\n6. Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)\n\nExclusion Criteria:\n\n1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)\n2. Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days\n3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study\n4. Any history of brain injury with loss of consciousness greater than 5 minutes\n5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)\n6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant\n7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range\n8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range\n9. Concomitant use of medications that could interfere with glutamatergic\u002FGABAergic transmission (e.g., benzodiazepines, ceftriaxone, riluzole, memantine, ketamine, topiramate, vigabatrin), due to potential confounding effects\n10. Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin\n11. Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded\n12. Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception\n13. Current suicidal or homicidal risk\n14. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale\n15. Has taken gabapentin in the last month or experienced adverse effects\u002Fallergic reaction (e.g., angioedema) from it at any time\n16. Significant claustrophobia and\u002For past negative experiences with MRI\n17. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)",{"count":300,"type":22},68,[60],"This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.",[28,304,305,30,31,306,307,308],"Cannabis Use","Schizoaffective Disorder, Bipolar Type","Cannabis Use Disorder, Mild","Cannabis Use Disorder, Moderate","Cannabis Use Disorder, Severe","2025-07-02",{"date":311,"type":40},"2025-07-08",{"date":313,"type":40},"2022-02-24",{"date":315,"type":22},"2026-06-30",{"name":317,"class":100},"Medical University of South Carolina"]