RECRUITING

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

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Conditions

Bipolar Disorder Type I With Mania or Mania With Mixed FeaturesBipolar-I disorderManiaBipolar-I disorder with Mania

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-06-13
Study Completion:2026-11-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06951711

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
  2. * Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
  3. * Participants must require hospitalization for the acute exacerbation or relapse of mania.
  4. * Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
  5. * Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
  6. * Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
  1. * 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.
  2. * Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
  3. * 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.
  4. * 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).
  5. * Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
  6. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Study Connect www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0014
Little Rock, Arkansas, 72204
United States
Local Institution - 0025
Rogers, Arkansas, 72758
United States
Local Institution - 0021
Culver City, California, 90230
United States
Local Institution - 0018
Riverside, California, 92506
United States
Local Institution - 0074
Torrance, California, 90502
United States
Local Institution - 0036
Hialeah Gardens, Florida, 33016
United States
Local Institution - 0032
Hollywood, Florida, 33021
United States
Local Institution - 0015
Miami Springs, Florida, 33166
United States
Local Institution - 0026
Miami, Florida, 33126
United States
Local Institution - 0019
Tampa, Florida, 33618
United States
Local Institution - 0022
Atlanta, Georgia, 30331
United States
Local Institution - 0016
Decatur, Georgia, 30030
United States
Local Institution - 0020
Chicago, Illinois, 60640
United States
Local Institution - 0024
Gaithersburg, Maryland, 20877
United States
Local Institution - 0017
Flowood, Mississippi, 39232
United States
Local Institution - 0023
Saint Louis, Missouri, 63141
United States
Local Institution - 0076
North Las Vegas, Nevada, 89030
United States
Local Institution - 0031
Marlton, New Jersey, 08053
United States
Local Institution - 0075
Charlotte, North Carolina, 28211
United States
Local Institution - 0029
Cincinnati, Ohio, 45219
United States
Local Institution - 0038
North Canton, Ohio, 44720
United States
Local Institution - 0012
DeSoto, Texas, 75115
United States
Local Institution - 0028
Houston, Texas, 77021
United States
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-13
Study Completion Date2026-11-02

Study Record Updates

Study Start Date2025-06-13
Study Completion Date2026-11-02

Terms related to this study

Keywords Provided by Researchers

  • Bipolar-I disorder
  • Mania
  • Bipolar-I disorder with Mania

Additional Relevant MeSH Terms

  • Bipolar Disorder Type I With Mania or Mania With Mixed Features