[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mania\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mania":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,73,101,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100603776","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-adjunctive-karxt-for-the-treatment-of-mania-with-or-without-mixed-features-in-participants-with-bipolar-i-disorder-taking-lithium-valproate-or-lamotrigine-100603776",false,"NCT07140913","A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","Inclusion Criteria:\n\n* Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.\n* Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).\n* The individual requires hospitalization for the acute exacerbation or relapse of mania.\n* Body mass index ≥ 18 and ≤ 40 kg\u002Fm2.\n* Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.\n* YMRS Total Score of ≥ 18 at Screening and at Baseline, and \\\u003C 20% reduction in YMRS from screening to baseline.\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.\n* Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.\n* Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer \"Yes\" to item 4 or 5 within 6 months before screening or between screening and baseline, or \"Yes\" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.\n* History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.\n* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.\n* Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and\u002For active hepatic viral infections based on either medical history or the LFT results.\n* Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and\u002For bilirubin \\> 1.5× ULN, unless in the context of Gilbert's syndrome.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years","65 Years",{"count":20,"type":21},424,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.",[27,28],"Mania","Bipolar Disorder",[30,27,31,32,33],"Bipolar-I Disorder","KarXT","adjunctive treatment","mood stabilizer","RECRUITING","2026-06-22",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":38},"2025-10-08",{"date":42,"type":21},"2027-06-28",{"name":44,"class":45},"Bristol-Myers Squibb","INDUSTRY",104,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100615108","phase-2-an-assessment-of-efficacy-safety-and-pharmacokinetics-of-nbi-1117568-in-adults-with-bipolar-i-disorder-with-current-mania-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":55,"type":21},150,[57],"PHASE2","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.",[60,27],"Bipolar I Disorder",[60,27,62],"NBI-1117568","2026-03-20",{"date":65,"type":38},"2026-03-24",{"date":67,"type":38},"2025-12-24",{"date":69,"type":21},"2028-02",{"name":71,"class":45},"Neurocrine Biosciences",6,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100473439","deep-brain-stimulation-induced-mania-in-parkinsons-disease-100473439","NCT05444907","Deep Brain Stimulation-Induced Mania in Parkinson's Disease","Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment","BPD_DBS","DBS-induced mania cohort:\n\nInclusion Criteria:\n\n* Age≥18-years-old;\n* Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target;\n* Manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters.\n\nExclusion Criteria:\n\n* Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18\n* Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state, before DBS surgery.\n\nDBS Control Cohort:\n\nA control cohort will also be collected. These patients will also meet the aforementioned inclusion and exclusion criteria with the exception of not having presented a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation.",{"count":82,"type":21},100,"OBSERVATIONAL","Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Nevertheless, this approach is, in some cases, associated with incapacitating neuropsychiatric side-effects, including mood disturbances, such as DBS-induced mania. While this condition has important functional short- and long-term consequences for quality of life and prognosis, its pathophysiology is still poorly understood. In this project the investigators propose to conduct a retrospective and naturalistic study in PD patients in whom DBS stimulation resulted in mania or mixed state episode, to clarify if specific sociodemographic and clinical predictors, namely stimulation parameters and target locations, might be associated to the occurrence of this neuropsychiatric adverse event. Additionally, the investigators aim to clarify if the occurrence of DBS-induced mania results from the impact of specific stimulation parameters and\u002For target locations in functional connectivity networks. To explore this question, the investigators will use different neuroimaging analysis methods termed lesion topography analysis and lesion network mapping, in order to compute maps of the stimulated regions topography and the functional networks that are associated with DBS-mania, respectively. The data that will be analyzed in this project, including neuroimages, will be obtained retrospectively, by different Movement Disorders and Functional Surgery Groups in the context of Deep Brain Stimulation, and that has been collected according to their usual clinical practice.",[27,86],"Parkinson Disease",[88,89,27],"Parkinson's Disease","Deep Brain Stimulation","2025-02-24",{"date":92,"type":38},"2025-02-26",{"date":94,"type":38},"2021-05-25",{"date":96,"type":21},"2025-12-31",{"name":98,"class":99},"Albino Maia","OTHER",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":100},"100573625","effect-of-blue-light-blocking-on-reducing-manic-symptoms-in-bipolar-disorder-100573625","NCT06748716","Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder","Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder: a Randomized Placebo-controlled Trial BLUME (Blue Light Filtering in Manic Episodes)","BLUME","Inclusion Criteria:\n\n* Patients hospitalized with manic symptoms in HUG\n* Diagnostic of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria\n* aged 18-70 years\n\nExclusion Criteria:\n\n* previous knowledge of blue-blocking glasses\n* not consenting to participate\n* severe eye disease or traumatic injury affecting both eyes.\n* withdrawal symptoms from any drug or alcohol at the time of admission (the start of the intervention will be delayed until withdrawal symptoms have ceased)","70 Years",{"count":111,"type":21},96,[113],"NA","This study will be a randomized controlled trial (RCT) measuring the efficacy of wearing blue-blocking glasses (orange glasses) on manic symptoms in a population of patients suffering from Bipolar Disorder (BD), hospitalized for a manic episode on 10 days compared to non-filtering glasses (clear glasses, placebo) in addition to pharmacological treatment as usual.\n\nThe primary objective of this study is to evaluate the efficacity of orange glasses on improving manic symptoms in adult patients presenting BD in comparison with placebo. The primary outcome will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. Secondary objectives will be change in sleep quality, in motor activity (patterns of activity and rest), impact on psychotics symptoms, kinetics of the decrease of the manic symptoms from inclusion to the study and impact on maximal administered antipsychotic medication dosage ; they will be explored.\n\nThe investigators hypothesize that orange glasses is more effective than placebo in improving manic symptoms as an adjuvant treatment.\n\nThis project will take place in Alizé unit which is a newly conceived specialized ward dedicated to treating BD, at the HUG. The methodology has been developed in collaboration with the center of clinical research (CRC). The study will be conducted in accordance with established ethical and data management\u002Fprotection practices.",[116,117,118,119,120,27,121,122],"Bipolar","Manic","Bipolar Disorder (BD)","Dark Therapy","Actigraphy","RCT","Virtual Darkness","NOT_YET_RECRUITING","2024-12-18",{"date":126,"type":38},"2024-12-27",{"date":128,"type":21},"2025-04-01",{"date":130,"type":21},"2028-04-01",{"name":132,"class":99},"Rayan NASSERDINE",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":100},"100493327","combining-mhealth-and-nurse-delivered-care-to-improve-the-outcomes-of-people-with-serious-mental-illness-in-west-africa-100493327","NCT05703711","Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa","Inclusion Criteria:\n\n* Aged 18 years or older\n* Speaks Twi or English\n* Current inpatient staying at a study prayer camp\n* A diagnosis of psychosis, mania, or depression\n\nExclusion Criteria:\n\n* Serious physical illness or in need of urgent medical attention",true,{"count":141,"type":21},360,[113],"In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.",[145,27,146],"Psychosis","Depression",[148,145,27,146],"mHealth","2024-07-23",{"date":151,"type":38},"2024-07-25",{"date":153,"type":38},"2023-10-25",{"date":155,"type":21},"2027-05-31",{"name":157,"class":99},"University of Washington"]