Recruiting
Phase 3

KarXT

Sponsor:

Bristol-Myers Squibb

Code:

NCT06951698

Conditions

Bipolar-I Disorder With Mania or Mania With Mixed Features

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

KarXT

Placebo

Study Details

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

Conditions

Bipolar-I Disorder With Mania or Mania With Mixed Features

Study ID

NCT06951698

Start date

Jun 11, 2025

Status verified date

Sep, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

274 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

Flexible dosing

placebo comparator: Placebo

Interventions

KarXT

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Change from baseline in Young Mania Rating Scale (YMRS) score [ Time Frame: At week 3 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

George Konis, Site 0011

501-221-8681

Advanced Research Center Inc.

Recruiting

Anaheim, California, United States, 92805

Contacts

Steven Macina, Site 0005

714-999-6688

CITrials

Recruiting

Bellflower, California, United States, 90706

Contacts

Robert Bota, Site 0008

562-748-4999

Collaborative Neuroscience Research, LLC

Recruiting

Long Beach, California, United States, 90806

Contacts

David Walling, Site 0059

714-799-7799

NRC Research Institute

Recruiting

Los Angeles, California, United States, 90015

Contacts

Tony Ortiz, Site 0053

714-289-1100

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

Stephen Volk, Site 0072

909-590-8409

Connecticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Deepak D'Souza, Site 0124

20393257112594

Research Centers of America ( Hollywood )

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Edwin Gomez, Site 0043

954-604-3900

Advanced Research Institute of Miami

Recruiting

Homestead, Florida, United States, 33033

Contacts

Moraima Trujillo, Site 0020

305-246-0001

South Florida Research Phase I-IV

Recruiting

Miami, Florida, United States, 33166

Contacts

Silvia Silva Duluc, Site 0069

305-669-6166

Innovative Clinical Research, Inc.

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Rishi Kakar, Site 0054

786-512-4106

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Mohammad Nisar, Site 0023

786-831-7303

Synexus Clinical Research US, Inc.

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Bethany Davis, Site 0009

404-255-6005

CenExel iResearch, LLC

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Michael Mobley, Site 0057

912-744-0800

Pillar Clinical Research -Chicago

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Roueen Rafeyan, Site 0047

312-865-6336

Richmond Behavioral Associates

Recruiting

Staten Island, New York, United States, 10314

Contacts

Peter Weiden, Site 0030

917-701-7484

Neuro-Behavioral Clinical Research

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Shishuka Malhotra, Site 0013

330-493-1118

Pillar Clinical Research - Richardson

Recruiting

Richardson, Texas, United States, 75080

Contacts

Scott Bartley, Site 0044

214-396-4844

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Bipolar-I
  • Mania
  • Mixed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-04.