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

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. 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.

Conditions

Bipolar Disorder Type I With Mania or Mania With Mixed Features

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Bipolar Disorder Type I With Mania or Mania With Mixed Features
Intervention / Treatment

-

Contacts and Locations

Little Rock

Local Institution - 0014, Little Rock, Arkansas, United States, 72204

Rogers

Local Institution - 0025, Rogers, Arkansas, United States, 72758

Culver City

Local Institution - 0021, Culver City, California, United States, 90230

Riverside

Local Institution - 0018, Riverside, California, United States, 92506

Hialeah Gardens

Local Institution - 0036, Hialeah Gardens, Florida, United States, 33016

Miami Springs

Local Institution - 0015, Miami Springs, Florida, United States, 33166

Miami

Local Institution - 0026, Miami, Florida, United States, 33126

Saint Petersburg

Local Institution - 0019, Saint Petersburg, Florida, United States, 33713

Atlanta

Local Institution - 0022, Atlanta, Georgia, United States, 30331

Decatur

Local Institution - 0016, Decatur, Georgia, United States, 30030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2026-11-02