A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Launched by BRISTOL-MYERS SQUIBB · Apr 23, 2025

Keywords

ClinConnect Summary

The BALSAM-2 clinical trial is studying a new medication called KarXT to see how effective and safe it is for treating manic episodes in people with Bipolar Disorder Type I. This study will involve participants who are currently experiencing a significant manic episode and need to be hospitalized for their treatment. Over the course of about seven weeks, participants will receive either KarXT or a placebo (a non-active treatment) for three weeks while being closely monitored.

To be eligible for this trial, participants must be adults diagnosed with Bipolar-I disorder and experiencing a recent episode of mania. They should have a specific score indicating the severity of their mania and must have stopped taking other psychiatric medications two weeks before starting the trial. Importantly, participants should not have other serious mental health issues or substance use disorders. Throughout the study, participants can expect regular check-ins and assessments to monitor their symptoms and overall safety. This trial is currently not recruiting participants, but it aims to help find better treatments for those living with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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, 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.