KarXT tested against placebo for manic episodes in bipolar I disorder
Tests KarXT against placebo in adults hospitalized with a manic episode of bipolar I disorder.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Key facts
- Where
- Ancona, Genova, Milan, Pisa, and Siena, ItalySee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06951711, who can take part
Where in Italy
- AnconaAncona, ItalyNo longer taking part
- GenovaGenova, ItalyNo longer taking part
- MilanMilan, ItalyNo longer taking part
- PisaPisa, ItalyNo longer taking part
- SienaSiena, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06951711
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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-2)
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.
The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
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 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 have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results; Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year); 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); Other protocol-defined Inclusion/Exclusion criteria apply.