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RECRUITING

NCT06951698

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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

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-1)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2025-06-11

Completion Date

2026-11-01

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Bipolar-I Disorder With Mania or Mania With Mixed Features

Interventions

DRUG

KarXT

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

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.

Locations (63)

Pillar Clinical Research - Bentonville

Bentonville, Arkansas, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Advanced Research Center Inc.

Anaheim, California, United States

CITrials

Bellflower, California, United States

Local Institution - 0014

Cerritos, California, United States

Collaborative Neuroscience Research, LLC

Long Beach, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

NRC Research Institute

Orange, California, United States

Connecticut Mental Health Center

New Haven, Connecticut, United States

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

Advanced Research Institute of Miami

Homestead, Florida, United States

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States

Local Institution - 0015

Miami Lakes, Florida, United States

South Florida Research Phase I-IV

Miami Springs, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Synexus Clinical Research US, Inc.

Atlanta, Georgia, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Pillar Clinical Research -Chicago

Chicago, Illinois, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

Local Institution - 0029

Irving, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Sanatorio Morra S.A.

Córdoba, Argentina

Local Institution - 0108

Mendoza, Argentina

Local Institution - 0109

Mendoza, Argentina

Ramsay Clinic Northside

St Leonards, New South Wales, Australia

Ramsay Clinic New Farm

Brisbane, Queensland, Australia

Center for Mental Health Prof. Dr. Ivan Temkov

Burgas, Bulgaria

State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar

Novi Iskar, Bulgaria

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD

Pleven, Bulgaria

MHAT "Dr. Ival Seliminski"

Sliven, Bulgaria

Mental Health Center - Vratsa

Vratsa, Bulgaria

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Local Institution - 0114

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Hotei Hospital

Kōnan, Aichi-ken, Japan

Okehazama Hospital

Toyoake, Aichi-ken, Japan

National Kohnodai Medical Center.

Ichikawa, Chiba, Japan

Local Institution - 0100

Kitakyushu, Fukuoka, Japan

Obihiro Kosei Hospital

Obihiro, Hokkaido, Japan

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, Japan

Kansai Medical University Medical Center

Moriguchi, Osaka, Japan

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, Japan

Local Institution - 0081

Iruma, Saitama, Japan

Saitama Konan Hospital

Kumagaya, Saitama, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Local Institution - 0084

Osaka, Japan

Showa Medical University Karasuyama Hospital

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Yamagata Sakuracho Hospital

Yamagata, Japan

North Shore Hospital

Auckland, New Zealand

Local Institution - 0095

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 0107

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0094

Bialystok, Podlaskie Voivodeship, Poland

Local Institution - 0111

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0103

Rybnik, Silesian Voivodeship, Poland

Local Institution - 0102

Sosnowiec, Silesian Voivodeship, Poland

Clinica Inventiva

Tuszyn, Poland