Bipolar-I Disorder
Conditions
Interventions
KarXT group: xanomeline/trospium chloride 50 mg/20 mg or 100 mg/20 mg or 125 mg/30 mg capsule BID
Placebo group: placebo capsule BID
Sponsors
Moran Lauren
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >Participant must be 18 to 65 years of age, inclusive, at the time of signing the ICF. >Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TRcriteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2). >Individual is experiencing an acute episodeor relapse of mania or mania with mixed features (The individual requires hospitalization for the acute exacerbation or relapse of mania. >All psychotropic medications are washed out in no more than 14 days prior to the first doseof the study drug. >Young Mania Rating Scale (YMRS) score of >= 20 at Screening and at Baseline. >Clinical Global Impressions-Bipolar(CGI-BP) >= 4at Screening and at Baseline.
Exclusion criteria
Exclusion criteria: >Any primary DSM-5-TR disorder,other than BP-I with mania or mania with mixed features within 12 months before screening (ie, primary focus of treatment, confirmed using MINI version 7.0.2 at screening),including BP-I withdepression(for previous 3 months only), BP-II disorder,major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. >Primary diagnosis of BP-I with rapid cycling (>= 4 distinct mood episodes in one year). >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. >Riskfor suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" onitems4 or 5 (C-SSRS -ideation) within 6 months of screening, or "Yes" to any of 5 items (C-SSRS -behavior)within 12 months of screeningor betweenscreening and baseline. >History ofirritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. >Historyor high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Young Mania Rating Scale (YMRS) scoreat Week 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in CGI-BP at Week 3. | — |
Countries
Argentina, Australia, Bulgaria, Hungary, Japan, New Zealand, Poland, United States
Contacts
Public ContactLauren Moran
Bristol-Myers Squibb
Outcome results
None listed