Recruiting
Phase 3

KarXT

Sponsor:

Bristol-Myers Squibb

Code:

NCT06951711

Conditions

Bipolar Disorder Type I 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:

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

Study ID

NCT06951711

Start date

Jun 13, 2025

Status verified date

Sep, 2026

Completion date

Nov 2, 2026

Anticipated

Primary completion date

Nov 2, 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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
  • 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

Pillar Clinical Research- Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith, Site 0014

501-350-3285

Woodland Research Northwest

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Robert Billingsley, Site 0025

479-927-3000

Proscience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

Marina Bussel, Site 0021

424-227-8127

Clinical Innovations, Inc. dba CITrials

Recruiting

Riverside, California, United States, 92506

Contacts

Evagelos Coskinas, Site 0018

951300492

Collaborative Neuroscience Research, LLC

Recruiting

Torrance, California, United States, 90502

Contacts

Lara Shirikjian, Site 0074

310-523-4200

Behavioral Clinical Research

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Olga Lapeyra, Site 0032

954-375-7794

LCC Medical Research Institute

Recruiting

Miami, Florida, United States, 33126

Contacts

Yesenia Kuan, Site 0026

305-400-0814

Innovative Clinical Research, Inc.

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Rishi Kakar, Site 0081

786-512-4106

South Florida Research Phase I-IV

Recruiting

Miami Springs, Florida, United States, 33166

Contacts

Silvia Silva Duluc, Site 0015

305-669-6166

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Mohammad Nisar, Site 0083

786-831-7303

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Elyssa Barron, Site 0022

404-881-5800

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Kimball Johnson, Site 0016

404-537-1281

CBH Health

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

Elia Acevedo Diaz, Site 0024

301-251-4702

Precise Research Centers

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Joseph Kwentus, Site 0017

601-420-5810

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Junaid Syed, Site 0023

314-771-6387

Hassman Research Institute Marlton Site

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Elan Cohen, Site 0080

267-981-8911

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Caleb Adler, Site 0029

513-404-0279

Neuro-Behavioral Clinical Research

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Shishuka Malhotra, Site 0038

330-493-1118

Adams Clinical Dallas

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Rajinder Shiwach, Site 0012

972-283-6286

Pillar Clinical Research - Richardson

Recruiting

Richardson, Texas, United States, 75080

Contacts

Scott Bartley, Site 0037

214-396-4844

Pillar Clinical Research

Recruiting

Richardson, Texas, United States, 75080

Contacts

Fayz Hudefi, Site 0095

479-367-2688

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

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

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