[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-i-disorder-with-mania-or-mania-with-mixed-features\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-i-disorder-with-mania-or-mania-with-mixed-features":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100589229","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-100589229",false,"NCT06951698","A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)","BALSAM-1","Inclusion Criteria\n\n* Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.\n* Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).\n* Participants must require hospitalization for the acute exacerbation or relapse of mania.\n* Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.\n* Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.\n* Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.\n\nExclusion Criteria:\n\n* Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n* Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).\n* Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.\n* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).\n* Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n* Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years","65 Years",{"count":21,"type":22},274,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder",[28],"Bipolar-I Disorder With Mania or Mania With Mixed Features",[30,31,32],"Bipolar-I","Mania","Mixed","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2025-06-11",{"date":41,"type":22},"2026-11-01",{"name":43,"class":44},"Bristol-Myers Squibb","INDUSTRY",69]