[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-i-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-i-disorder":488},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,46,78,105,134,159,182,212,231,255,277,326,352,386,416,441,464],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100422171",false,"NCT04777357","A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.","A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder","3112 Ped BPD","Inclusion Criteria:\n\n* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Current depressive episode is more than 2 weeks and less than 12 months in duration.\n* Participant has a lifetime history of at least one manic episode.\n* Children's Depression Rating Scale - Revised (CDRS-R) score \\> = 45 at Visit 1 and Visit 2.\n* Young-Mania Rating Scale (YMRS) score \\\u003C = 12 with YMRS Item 1 (elevated mood) score \\\u003C = 2 at Visit 1 and Visit 2.\n* Clinical Global Impression-Severity (CGI-S) scale score of \\> = 4 (moderately ill) at Visit 1 and Visit 2.\n\nExclusion Criteria:\n\n* Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.\n* Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 1.\n* History of serotonin syndrome or neuroleptic malignant syndrome.\n* Four or more episodes of a mood disturbance within the 12 months before Visit 1.\n* DSM-5 diagnosis of intellectual disability (IQ \\\u003C 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.\n* History of seizures, with the exception of febrile seizures.\n* Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.\n* Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.\n* Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.\n* Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.\n* Treatment with clozapine in a dose of \\>= 50 mg\u002Fd in the past 2 years.\n* History of or any current ocular disease including, but not limited to, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).","ALL","10 Years","17 Years",{"count":20,"type":21},380,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.\n\nCariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.\n\nParticipants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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.",[27,28],"Depression","Bipolar I Disorder",[27,30,28,31,32],"RGH-188","Vraylar","Cariprazine","RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2021-04-28",{"date":41,"type":21},"2027-03",{"name":43,"class":44},"AbbVie","INDUSTRY",81,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100503580","NCT05837104","Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder","Inclusion Criteria:\n\n* Persons between the ages of 18 and 50\n* DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years\n* Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.\n* Young Mania Rating Scale (YMRS) scores of less than 15\n* Ability to sign informed consent.\n* Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent.\n* Persons weighing over 350lbs.\n* Declines to participate.\n* Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.\n* 2 or more manic symptoms that meet DSM-V criteria.\n* Persons of childbearing potential who are not using a medically accepted means of contraception.\n* Persons who are deemed a serious suicide or homicide risk.\n* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.\n* The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder.\n* Persons meeting criteria for bipolar mixed episode.\n* Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.\n* Severe hypomagnesemia (serum magnesium of 0.45 mmol\u002FL).\n* Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.\n* Seizure disorder.\n* Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.\n* Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.\n* Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months.\n* Have any medical condition that would prevent blood draws.\n* Have a history of significant head injury.\n* Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n* Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6\n* Patients taking psychostimulant medication","18 Years","50 Years",{"count":55,"type":21},40,[57],"PHASE2","This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.",[28,60,61],"Depression, Anxiety","Stress",[63,64,65,27,66,61],"First episode Bipolar Disorder","Magnesium vitamin B6","Brain energy metabolism","Anxiety","2026-06-22",{"date":69,"type":37},"2026-06-25",{"date":71,"type":37},"2023-12-13",{"date":73,"type":21},"2026-10",{"name":75,"class":76},"Mclean Hospital","OTHER",1,{"id":79,"slug":4,"hasResults":10,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100462546","NCT05303064","Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder","A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ\u002FSAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)","Inclusion Criteria:\n\n* Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria\n* Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2\n* Subject has reliable family\u002Flegal guardian support available for outpatient management\n* Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment\n* Subject must not be a danger to self or others (per Investigator judgement)\n\nExclusion Criteria:\n\n* Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and\u002For unstable, or any other psychiatric condition that could interfere with participation in the study\n* Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening\n* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Subject has received olanzapine for \\>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine\n* Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)\n* Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)\n* Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening\n* Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening\n* Subject has a BMI percentile \\>98th or \\\u003C5th\n* Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \\[HbA1c\\] \\>= 6%)\n* Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening\n* Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening",{"count":85,"type":21},220,[24],"To compare changes in body mass index (BMI) Z-score following treatment with OLZ\u002FSAM vs olanzapine",[89,28],"Schizophrenia",[91,89,28,92,93,94],"LYBALVI","Pediatric","Olanzapine","Samidorphan","2026-06-02",{"date":97,"type":37},"2026-06-03",{"date":99,"type":37},"2022-06-30",{"date":101,"type":21},"2026-09",{"name":103,"class":44},"Alkermes, Inc.",47,{"id":106,"slug":4,"hasResults":10,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"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":114,"type":21},400,[24],"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).",[118,119,28,120],"Bipolar Disorder","Bipolar Depression","Bipolar II Disorder",[122,123,124],"Bipolar","XEN1101","Azetukalner","2026-06-01",{"date":97,"type":37},{"date":128,"type":37},"2025-08-08",{"date":130,"type":21},"2028-08",{"name":132,"class":44},"Xenon Pharmaceuticals Inc.",28,{"id":135,"slug":4,"hasResults":10,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"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":142,"type":21},195,[57],"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.",[28,120],[28,120,118,147,148,149],"lcalcaprant","ABBV-1354","CVL-354","2026-05-11",{"date":152,"type":37},"2026-05-13",{"date":154,"type":37},"2026-02-03",{"date":156,"type":21},"2027-11",{"name":43,"class":44},31,{"id":160,"slug":4,"hasResults":10,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100630948","NCT07494305","Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.","A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder","Illuminate1","Inclusion Criteria:\n\n* Sign IRB approved ICF, Stable living environment\n* Diagnosis of Bipolar1 disorder defined by criteria in the DSM 5 and currently experiencing a MDE without psychotic or mixed features, and supported by the SCID 5 CT\n* Currently experiencing an MDE that began at least 4 weeks but no more than 18 months prior to randomization\n* Currently treated in an out-patient environment\n* MADRS 10 total score ≥24 at both Screening and Baseline with a difference of \\\u003C20% in scores between visits.\n* Clinical Global Impression Scale, Bipolar Version Severity of Illness scale (CGI BP S) depression score ≥4 at both Screening and Baseline.\n* YMRS total score ≤12 at both Screening and Baseline.\n* Good physical health\n* BMI of ≥18 and ≤40 kg\u002Fm2.\n* Eligibility confirmed centrally for the severity, diagnosis, and treatment history by the SAFER interview.\n\nExclusion Criteria:\n\n* Sexually active woman of childbearing potential and male who are not practicing 2 different methods of birth control or woman who is currently breast feeding\n* History of non-response to 2 adequate medication trials for depressive symptoms\n* Improvement of ≥20% in MADRS 10 total score between the screening and baseline assessments\n* Have bipolar disorder with mixed features or considered as rapid cyclers\n* Plan to initiate formal cognitive or behavioral therapy, systematic psychotherapy during the study, or plan to initiate such therapy during the study\n* History of disorders other than bipolar disorder, confirmed by previous psychiatric evaluation or the DSM 5 within 12 months prior to Screening\n* Experience of hallucinations, delusions, or any other psychotic symptomatology in the current MDE attributable to a primary DSM 5 diagnosis other than bipolar disorder.\n* Hospitalized for mania associated with Bipolar I Disorder within 30 days prior to Screening. Any previous manic phase must have completely resolved before enrollment in the study.\n* Significant risk for suicidal behavior during the study as determined by the Investigator's clinical assessment\n* Hypo or hyperthyroidism\n* Insulin dependent diabetes\n* Uncontrolled hypertension\n* Known significant cardiac disease\n* Laboratory results outside the defined protocol ranges\n* Clinically significant abnormal ECG findings\n* Received electroconvulsive therapy (ECT) within 90 days prior to Screening.\n* Received Transcranial Magnetic Stimulation within 90 days prior to Screening\n* Currently taking prohibited medications as defined in the protocol\n* History of non-response and\u002For responded only to ketamine, ECT or vagus nerve stimulation\n* Received GLP-1 within 30 of screening\n* History of organ disease that in the opinion of the PI would not make the patient eligible for participation",{"count":167,"type":21},320,[57],"Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.",[28],[122,172],"Major depression episode","2026-05-07",{"date":150,"type":37},{"date":176,"type":37},"2026-01-23",{"date":178,"type":21},"2028-02",{"name":180,"class":44},"LB Pharmaceuticals Inc.",26,{"id":183,"slug":4,"hasResults":10,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100607227","NCT07185815","Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine","A Prospective, Dose Escalating, Open Label, Multi-center, Phase I\u002FIIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.","Key Inclusion Criteria:\n\n* Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).\n* Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic\u002Fs or antidepressant\u002Fs other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg\u002Fday, with CGI-S score of 1-4.\n* Men and women aged 18-64 years (inclusive).\n* Body mass index (BMI) 18.5-35.\n* Able to sign an informed consent form.\n* Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only).\n\nKey Exclusion Criteria:\n\n* Subjects with schizophrenia with PANSS item scores of \\> 4 on any of the following: P4 Excitement\u002FHyperactivity; P6 Suspiciousness\u002Fpersecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.\n* Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.\n* Use of an investigational drug, and\u002For participation in clinical studies with an investigational product within 3 months prior to screening.\n* History or current cardiovascular or cerebrovascular disease.\n* History of seizures or conditions that lower the seizure threshold.\n* Use of concomitant administration of strong or moderate CYP3A4 inhibitors.\n* Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.\n* Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years.\n* Subjects with a history of orthostatic hypotension and\u002For syncope.\n* Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).\n* Subjects with CGI-S score of 5-7.\n* Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.\n* For cohort 3 only: Subjects treated with oral Clozapine.","64 Years",{"count":190,"type":21},24,[192,57],"PHASE1","The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.",[89,28,195],"Major Depressive Disorder",[197,198,199,200,32,201],"Long acting injection","LAI","Subcutaneous","SC","Cariprazine Depot","2026-04-27",{"date":204,"type":37},"2026-05-01",{"date":206,"type":37},"2025-08-01",{"date":208,"type":21},"2027-06-03",{"name":210,"class":44},"Mapi Pharma Ltd.",6,{"id":213,"slug":4,"hasResults":10,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":77},"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":55,"type":21},[221],"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.",[119,28,120],{"date":204,"type":37},{"date":226,"type":37},"2025-07-10",{"date":228,"type":21},"2027-02-26",{"name":230,"class":76},"University of Ottawa",{"id":232,"slug":4,"hasResults":10,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":77},"100634488","NCT07540338","A Study to Investigate Lithium Brain\u002FPlasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder","A Randomized, Balanced, Phase 1\u002F2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain\u002FPlasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder","Inclusion Criteria:\n\n1. Subjects with Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by a DSM-5-TR BD1 diagnosis and the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests.\n2. Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of \\\u003C 8 and a Hamilton Depression Rating Scale (HDRS-17) rating of \\\u003C 16 at the Screening visit and on Day -1 (P1). Subsyndromal depression has not significantly worsened in the 4 weeks prior to randomization on Day -1 (P1) so as to avoid enrolling subjects who are on the verge of a full depressive episode. Assessment of subject's suicidal ideation and behavior (SI\u002FB) using the Columbia-Suicide Severity Rating Scale (C-SSRS) will be conducted to avoid enrolling subjects with concerning results, defined as a lifetime history of a suicide attempt, past year level 4 or higher suicidal ideation on the C-SSRS, or past month suicidal ideation of any kind. The \"Lifetime\u002FRecent\" version will be used at screening and the \"Since Last Visit\" version will be used subsequently.\n3. Clinically acceptable, stably dosed mood stabilizing medication regimen, including treatment regimens with atypical antipsychotic drugs, for \\> 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for a list of medications not allowed for mood stabilization purposes. Exceptions to this may be made on a case-by-case basis following agreement by the Investigator and the Sponsor. Also, subjects with untreated BD1 can be enrolled if deemed adequately stable by the Investigator.\n4. Able to understand and follow instructions during the study as determined by the Investigator.\n5. Willing to follow study procedures.\n6. Willing and able to adhere to study restrictions and to be confined at the clinical research center per protocol requirements.\n7. Any gender, race, or ethnicity.\n8. Able to understand and provide written informed consent.\n9. Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until after Treatment Period 2 in-clinic follow-up visit on Day 23 (P2).\n10. Females must meet one of the following criteria:\n\n    Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:\n    1. Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after the last dose of the study drug on Day 14 (P2).\n    2. One of the following highly-effective contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after the last dose of the study drug on Day 14 (P2).\n\n       * i. Systemic contraceptives (combined birth control pills, injectable\u002Fimplant\u002Finsertable hormonal birth control products, or transdermal patch).\n       * ii. Intrauterine device (with or without hormones)\n       * iii. Male partner vasectomized at least 6 months prior to the Screening visit.\n    3. One of the following double-barrier contraceptive methods, used from the Screening visit through to at least 30 days after the last dose of the second study drug on Day 14 (P2):\n\n       * i. Male condom used simultaneously with diaphragm plus spermicide.\n       * ii. Male condom used simultaneously with cervical cap plus spermicide.\n\n    Or\n\n    Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation), or is in a postmenopausal state (i.e., at least 1 year without menses prior to the Screening visit).\n11. Able to communicate in English, including speaking, reading, and writing.\n12. Body mass index (BMI) within 18.0 to 31.0 kg\u002Fm2, inclusive, and body weight of at least 50 kg at the time of Screening.\n13. ECG recording, after at least 5 minutes of rest in a supine position, without clinically significant abnormalities as determined by the Investigator.\n\nExclusion Criteria:\n\n1. Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings (including prolonged QT interval), or clinical laboratory findings (as determined by the Investigator) that may affect the safety or successful participation of the subject. Specifically, evidence of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, dermatologic, muscular, or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) that may affect the safety or successful participation of the subject.\n2. Any history of drug hypersensitivity or asthma (with the exception of childhood asthma), urticaria or other severe allergic diathesis.\n3. Presence or history of any disorder other than the diagnosis under study that may prevent the successful completion of the study.\n4. Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.\n5. History of seizure disorder and\u002For severe head trauma (other than a single childhood febrile seizure).\n6. History or presence of gastrointestinal disease including chronic gastritis, peptic ulcers, inflammatory bowel disease, hemorrhagic gastritis, or duodenitis.\n7. History or presence of acute or chronic liver disease as determined by the Investigator.\n8. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study treatments.\n9. Any history of frequent headache or migraine.\n10. Kidney disease (eGFR \\\u003C 60 mL\u002Fminute\u002F1.73 m2).\n11. Uncontrolled tachy\u002Fbrady arrhythmias, atrial fibrillation, or coronary heart failure.\n12. Systemic related exclusions:\n\n    1. Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy.\n    2. Positive test results for HIV, HBV, or HCV (unless quantitative PCR negative for HCV) at Screening.\n    3. Severe hepatic impairment (Child-Pugh Class C).\n    4. Uncontrolled hypertension with a sustained blood pressure \\> 160\u002F100 mmHg at Screening, or at check-in on Day -1 (P1).\n    5. Fever (body temperature \\> 101.4°F \\[38.5°C\\]), acute upper respiratory, or any other infections at Screening, or at check-in on Day -1 (P1).\n13. Psychiatric or neurological illnesses other than-and not associated with-bipolar I disorder (e.g., bipolar II disorder exclusively, schizophrenia or other psychotic syndromes, Parkinson's disease and related movement disorders, seizure disorder, and myasthenia gravis).\n14. Treatment with haloperidol, antipsychotics (except stable regimens), monoamine oxidase inhibitors, neuromuscular blocking agents. Subjects who have ever received chronic immunosuppressant treatment (excluding topical or oral corticosteroids taken 1 year and 5 years before Screening, respectively).\n15. Current and during lithium treatment hyponatremia, defined as serum sodium laboratory value outside the standard reference range.\n16. The regular and long-term use of any medication, supplement, or OTC medication within 14 days prior to the Screening visit or at least 6 times the respective elimination half-life, whichever is longer, through the completion of the study on Day 42 (P2). EXCEPTIONS to this are as follows:\n\n    1. Hormonal contraceptives for females of childbearing potential.\n    2. Acetaminophen (up to 1000 mg TID) at the discretion of the Investigator.\n    3. Low-Dose aspirin for cardio protection.\n    4. Non-medicated ophthalmic products (for lubrication and comfort).\n    5. Clinically acceptable, stably dosed mood stabilizing medication regimen for \\> 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for list of medications not allowed for mood stabilization purposes. Exceptions to this may be made on a case-by-case basis following agreement by the Investigator and the Sponsor.\n    6. PRN medications needed for treatment of AE's during the study at the joint discretion of the Investigator and the Sponsor, reviewed on a case-by-case basis.\n17. Subjects treated with electroconvulsive therapy within 6 months prior to Screening visit.\n18. Unwilling to refrain from consumption of poppy seeds or quinine (tonic water) 48 hours prior to check-in on Day -1 (P1) and throughout the course of the study.\n19. Aspirin\u002Fnasal polyposis\u002Fasthma syndrome.\n20. Female who is breastfeeding.\n21. Female who is pregnant according to the pregnancy test at Screening or on Day -1 (P1); female planning to become pregnant during the study.\n22. History of adverse or hypersensitivity reaction to lithium, aspirin, salicylate, L-proline, or any investigational or reference article excipient.\n23. Drug\u002Falcohol abuse:\n\n    1. History of drug abuse (barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis) within the last 12 months or a positive urine drug screen at Screening or Day -1 (P1).\n    2. Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements or positive ethanol (alcohol) test at Screening or Day -1 (P1).\n    3. More than moderate current alcohol consumption. Subjects will be advised to consume no more than 2 units of alcohol per day and completely abstain from 72 hours prior to any study visit (1 unit is equal to approximately 10 g of pure alcohol, \\[250 mL\\] of beer \\[5%\\], 1 small glass \\[100 mL\\] of wine \\[12%\\], or 35 mL of spirits \\[35%\\]).\n24. Demonstrating excess xanthine consumption (e.g., ingests more than 5 cups of coffee or equivalent per day). Also, subject is not willing to refrain from xanthine products for 48 hours prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2). The subject is not willing to refrain from grapefruit, pomelo, Seville orange products or juice within 14 days prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2). Exceptions may be made on a case-by-case basis following agreement by the Principal Investigator and the Sponsor.\n25. Participation in a clinical trial and receipt of an investigational medication within 30 days or 5 half-lives (if known), whichever is greater, prior to the first dose of the current study drug.\n26. History of untreated thyroid dysfunction (due to potential lithium drug-disease interaction).\n27. Screening MRI-related exclusion criteria: intracranial mass, evidence of other anatomical findings that might affect safety or causes of cognitive\u002Fbehavioral impairment as assessed by a qualified neurologist. Subjects must not have any implantable medical device (e.g., anueurysm clip, vagus nerve stimulator, cardiac pacemaker) or be reliant on a non-removable medical device (e.g., insulin pump) unless that device is certified as MRI compatible. Known intolerability to MRI neuroimaging procedures.\n28. Subjects with any past apparent suicide attempt or suicidal behavior, including those with a lifetime history of suicide attempt(s) or a past year level 4 or higher SI\u002FB (C-SSRS) or past month SI\u002FB (C-SSRS) of any kind.\n29. Suspected of having or at risk for Brugada Syndrome.\n30. Central nervous system-related exclusions: Any medical condition that in the Investigator's judgement could affect subject safety and scientific integrity of the study, e.g., untreated hypothyroidism (TSH \\>10 mIU\u002FL) or vitamin B12 deficiency (vitamin B12 \\\u003C300 pg\u002FmL) which may contribute to cognitive impairment, delirium, dementia and other encephalopathies.",{"count":238,"type":21},20,[192,57],"The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are:\n\n* How safe is AL001 when compared to lithium carbonate?\n* How is AL001 broken down in the brain and body compared to lithium carbonate?\n\nParticipants will be asked to:\n\n* Take both the study drug (AL001) and lithium carbonate each for a period of 14 days.\n* Stay overnight at MGH's research unit for two separate 2-week periods.\n* Participate in two separate 24 hour periods of multiple MRIs and blood draws.",[28],[243,244,245],"Neurology","Psychiatry","Pharmacokinetics","2026-04-17",{"date":248,"type":37},"2026-04-20",{"date":250,"type":21},"2026-04",{"date":252,"type":21},"2026-12",{"name":254,"class":44},"Alzamend Neuro, Inc.",{"id":256,"slug":4,"hasResults":10,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":275,"locationsCount":211},"100615108","NCT07288320","An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of bipolar I disorder.\n* The participant has had at least 1 prior documented manic episode that required treatment.\n* The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.\n\nKey Exclusion Criteria:\n\n* Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.\n* Primary diagnosis is not bipolar I disorder.\n* History of clozapine treatment for treatment-resistant psychosis.\n* History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.",{"count":262,"type":21},150,[57],"The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.",[28,266],"Mania",[28,266,268],"NBI-1117568","2026-03-20",{"date":271,"type":37},"2026-03-24",{"date":273,"type":37},"2025-12-24",{"date":178,"type":21},{"name":276,"class":44},"Neurocrine Biosciences",{"id":278,"slug":4,"hasResults":10,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":10,"sex":16,"minAge":283,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":287,"conditions":288,"keywords":310,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":77},"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":285,"type":21},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.",[289,290,291,292,293,294,295,296,297,298,28,299,120,300,301,302,303,304,305,306,307,308,309],"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)",[311,312,313,314,315,316],"Life History Calendar","CIDI","Recall bias","Retrospective reporting","Lifetime prevalence","Mental disorders","2026-03-09",{"date":319,"type":37},"2026-03-10",{"date":321,"type":37},"2025-01-18",{"date":323,"type":21},"2027-04",{"name":325,"class":76},"The University of Hong Kong",{"id":327,"slug":4,"hasResults":10,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":77},"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":334,"type":21},100,[336],"PHASE4","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.",[28,120,339,340,341,342],"Schizo Affective Disorder","Obesity","Weight Loss","GLP - 1","2026-03-06",{"date":345,"type":37},"2026-03-11",{"date":347,"type":37},"2026-01-19",{"date":349,"type":21},"2029-02-01",{"name":351,"class":76},"Mayo Clinic",{"id":353,"slug":4,"hasResults":10,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":10,"sex":16,"minAge":359,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":363,"conditions":364,"keywords":369,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"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":362,"type":21},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.",[118,28,120,365,366,367,368],"Other Specified Bipolar and Related Disorder","Mood Instability","Child Mental Disorder","Adolescent - Emotional Problem",[370,371,372,373,374,375],"medication","psychosocial","treatment","longitudinal","naturalistic","assessment","2026-02-02",{"date":378,"type":37},"2026-02-05",{"date":380,"type":37},"2022-07-01",{"date":382,"type":21},"2027-07-01",{"name":384,"class":76},"University of California, Los Angeles",4,{"id":387,"slug":4,"hasResults":10,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":77},"100533133","NCT06221852","Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder","A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.","Inclusion Criteria:\n\n* Between the ages of 18 and 45.\n* Ability to adhere to study diets.\n* Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.\n* Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening\n* Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindication to magnetic resonance (MR) scan (including claustrophobia)\n* Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)\n* Current DSM-5 substance use disorder\n* Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception\n* Have a body weight of over 350 lbs or a body mass index (BMI) \\\u003C20\n* Score above 15 on the Young Mania Rating Scale (YMRS)\n* History of significant head injury\n* Current cancer diagnosis\n* Current diagnosis of type 1 or type 2 Diabetes Mellitus\n* History of gastric bypass surgery or any weight loss surgery\n* Concomitant treatment with Propofol\n* Familial hypercholesterolemia","45 Years",{"count":394,"type":21},50,[221],"This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.",[28,398,399],"Psychosis","Schizoaffective Disorder",[401,402,403,65,404,399,118,405,406,407],"First episode psychosis","Ketogenic Diet","Keto","Insulin resistance","Magnetic resonance spectroscopy (MRS)","Redox","Creatine kinase","2025-11-04",{"date":410,"type":37},"2025-11-05",{"date":412,"type":37},"2024-03-12",{"date":414,"type":21},"2027-12-30",{"name":75,"class":76},{"id":417,"slug":4,"hasResults":10,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":77},"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":423,"type":21},68,[57],"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.",[118,427,428,28,120,429,430,431],"Cannabis Use","Schizoaffective Disorder, Bipolar Type","Cannabis Use Disorder, Mild","Cannabis Use Disorder, Moderate","Cannabis Use Disorder, Severe","2025-07-02",{"date":434,"type":37},"2025-07-08",{"date":436,"type":37},"2022-02-24",{"date":438,"type":21},"2026-06-30",{"name":440,"class":76},"Medical University of South Carolina",{"id":442,"slug":4,"hasResults":10,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":10,"sex":16,"minAge":447,"maxAge":18,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":463},"100489090","NCT05648591","Safety and Tolerability of Open-Labeled Iloperidone in Adolescents","Open-label Safety Study of a 1-year 8 to 24 mg\u002FDay Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder","Inclusion Criteria:\n\n* Patient is willing and able to provide assent and willing to complete all aspects of the study\n* Patient's parent or legal guardian willing and able to provide consent\n* Male or female patients 12 through 17 years of age (inclusive)\n* Clinical diagnosis of either schizophrenia or bipolar I disorder\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer\n* A positive test for drugs of abuse","12 Years",{"count":334,"type":21},[336],"To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.",[89,28],[453],"fanapt","2025-02-27",{"date":456,"type":37},"2025-03-04",{"date":458,"type":37},"2023-05-24",{"date":460,"type":21},"2026-11-30",{"name":462,"class":44},"Vanda Pharmaceuticals",9,{"id":465,"slug":4,"hasResults":10,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":10,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":77},"100514325","NCT05977023","NMDA Receptor Modulation for the Treatment of Bipolar I Disorder","NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder","Inclusion Criteria:\n\n* Are 18 to 65 years of age;\n* Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, current episode depressed, after treatment of stable (i.e., at least 4 weeks) and adequate treatment of antipsychotic (quetiapine or lurasidone) and\u002For mood stabilizer;\n* Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young Mania Rating Scale (YMRS) score ≤7 at baseline;\n* Agree to participate in the study and provide informed consent\n\nExclusion Criteria:\n\n* Current substance abuse or history of substance dependence in the past 6 months\n* History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study\n* Schizophrenia or other psychotic disorder\n* Moderate-severe suicidal risks\n* Severe cognitive impairment\n* Clinically significant laboratory screening tests (including blood routine, biochemical tests)\n* Pregnancy or lactation;\n* Inability to follow protocol",{"count":471,"type":21},90,[57],"At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.",[28],[476,477,478],"Bipolar I disorder","Bipolar depression","NMDA","2025-02-16",{"date":481,"type":37},"2025-02-19",{"date":483,"type":37},"2023-10-04",{"date":485,"type":21},"2027-12",{"name":487,"class":76},"China Medical University Hospital",""]