RecruitingPhase 3NCT06951711

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

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-2)

Sponsor

Bristol-Myers Squibb

Enrollment

274 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder Type I With Mania or Mania With Mixed Features

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.

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 disorder type i with mania or mania with mixed features. The study is currently recruiting participants at 78 locations.

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(85)

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Proscience Research Group

Culver City, California, United States

Clinical Innovations, Inc. dba CITrials

Riverside, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Local Institution - 0036

Hialeah Gardens, Florida, United States

Behavioral Clinical Research

Hollywood, Florida, United States

LCC Medical Research Institute

Miami, Florida, United States

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States

South Florida Research Phase I-IV

Miami Springs, Florida, United States

Local Institution - 0019

Tampa, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

Local Institution - 0020

Chicago, Illinois, United States

CBH Health

Gaithersburg, Maryland, United States

Precise Research Centers

Flowood, Mississippi, United States

Arch Clinical Trials

St Louis, Missouri, United States

Local Institution - 0076

North Las Vegas, Nevada, United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States

Local Institution - 0031

Marlton, New Jersey, United States

Local Institution - 0075

Charlotte, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

Adams Clinical Dallas

DeSoto, Texas, United States

Local Institution - 0028

Houston, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Pillar Clinical Research

Richardson, Texas, United States

Local Institution - 0106

Wuhu, Anhui, China

Local Institution - 0103

Beijing, Beijing Municipality, China

Local Institution - 0108

Wuhan, Hubei, China

Local Institution - 0107

Changsha, Hunan, China

Local Institution - 0105

Jining Shi, Shandong, China

Local Institution - 0104

Tianjin, Tianjin Municipality, China

Local Institution - 0009

Zagreb, City of Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Psihijatrijska bolnica "Sveti Ivan"

Zagreb, Croatia

GMERS Medical College and General Hospital

Vadodara, Gujarat, India

Local Institution - 0082

Belagavi, Karnataka, India

Chethana Center for Neuropsychiatry

Kozhikode, Kerala, India

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

Asha Hospital - Hyderabad

Hyderabad, Telangana, India

Local Institution - 0055

Hyderabad, Telangana, India

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, India

Local Institution - 0096

Kolkata, West Bengal, India

Shalvata Mental Health Center

Hod HaSharon, Central District, Israel

Ness Ziona Mental Health Center

Ness Ziona, Central District, Israel

Local Institution - 0058

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Be'er Sheva Mental Health Center

Beersheba, Southern District, Israel

Kfar Shaul Mental Health Center

Jerusalem, Israel

Local Institution - 0001

Milan, Lombardy, Italy

Local Institution - 0056

Pisa, Tuscany, Italy

Local Institution - 0007

Siena, Tuscany, Italy

Local Institution - 0041

Ancona, Italy

Local Institution - 0040

Genova, Italy