Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder Type I With Mania or Mania With Mixed Features
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features....
Eligibility Criteria
Inclusion
- Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
- Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
- Participants must require hospitalization for the acute exacerbation or relapse of mania.
- Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
- Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
- Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
Exclusion
- 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.
- Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
- 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.
- 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).
- Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2026
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT06951711
Start Date
June 13 2025
End Date
November 2 2026
Last Update
December 23 2025
Active Locations (69)
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1
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
2
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
3
Proscience Research Group
Culver City, California, United States, 90230
4
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States, 92506