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

Description

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Conditions

Bipolar-I Disorder With Mania or Mania With Mixed Features

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

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-1)

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

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

-

Contacts and Locations

Bentonville

Local Institution - 0058, Bentonville, Arkansas, United States, 72712

Little Rock

Local Institution - 0011, Little Rock, Arkansas, United States, 72211

Anaheim

Local Institution - 0005, Anaheim, California, United States, 92805

Bellflower

Local Institution - 0008, Bellflower, California, United States, 90706

Cerritos

Local Institution - 0014, Cerritos, California, United States, 90703

Long Beach

Local Institution - 0059, Long Beach, California, United States, 90806

Montclair

Local Institution - 0072, Montclair, California, United States, 91763

Orange

Local Institution - 0053, Orange, California, United States, 92868

Lauderhill

Local Institution - 0054, Lauderhill, Florida, United States, 33319

Miami Lakes

Local Institution - 0015, Miami Lakes, Florida, United States, 33016

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 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 a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  • * Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  • * 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

2026-11-01