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Status:

RECRUITING

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Bipolar-I Disorder With Mania or Mania With Mixed Features

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

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

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects with bipolar disorder experiencing an acute episode of mania or mania with mixed features. Th...

Eligibility Criteria

Inclusion

  • 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, borderline personality 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.

Exclusion

    Key Trial Info

    Start Date :

    June 11 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2026

    Estimated Enrollment :

    274 Patients enrolled

    Trial Details

    Trial ID

    NCT06951698

    Start Date

    June 11 2025

    End Date

    November 1 2026

    Last Update

    December 17 2025

    Active Locations (63)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 16 (63 locations)

    1

    Pillar Clinical Research - Bentonville

    Bentonville, Arkansas, United States, 72712

    2

    Woodland International Research Group

    Little Rock, Arkansas, United States, 72211

    3

    Advanced Research Center Inc.

    Anaheim, California, United States, 92805

    4

    CITrials

    Bellflower, California, United States, 90706