RecruitingPhase 3NCT06951698

A Study 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)

Sponsor

Bristol-Myers Squibb

Enrollment

274 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Bipolar-I Disorder With Mania or Mania With Mixed Features

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KarXT and Placebo for people with bipolar-i disorder with mania or mania with mixed features. The study is currently recruiting participants at 63 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Locations(69)

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

South Florida Research Phase I-IV

Miami, Florida, United States

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States

Local Institution - 0015

Miami Lakes, 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

Clinica del Prado

Las Heras, Mendoza Province, Argentina

Sanatorio Morra S.A.

Córdoba, 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

Semmelweis Egyetem

Budapest, Hungary

Local Institution - 0114

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

Centrum Medyczne HCP

Poznan, Greater Poland Voivodeship, Poland

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland

Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku

Bialystok, Podlaskie Voivodeship, Poland

Local Institution - 0111

Gdansk, Pomeranian Voivodeship, Poland

M2M Med

Rybnik, Silesian Voivodeship, Poland

Local Institution - 0102

Sosnowiec, Silesian Voivodeship, Poland

Clinica Inventiva

Tuszyn, Poland

Local Institution - 0131

Smila, Cherkasy Oblast, Ukraine

Local Institution - 0130

Dnipro, Ukraine

Local Institution - 0126

Kropyvnytskyi, Ukraine

Local Institution - 0129

Kyiv, Ukraine

Local Institution - 0132

Poltava, Ukraine

Local Institution - 0137

Ternopil, Ukraine

View Full Details on ClinicalTrials.gov

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NCT06951698