What is KarXT studying for Bipolar-I disorder with manic episodes?

KarXT is being studied to see how well it works compared to placebo in treating symptoms of mania in people with Bipolar-I disorder during a 3-week inpatient period. The study aims to understand if KarXT can reduce manic symptoms effectively. Bristol-Myers Squibb is the lead sponsor conducting this research.

Who may be eligible for this Bipolar-I disorder clinical trial?

Adults aged 18 to 65 with a diagnosis of Bipolar-I disorder currently experiencing an acute manic episode or mania with mixed features that requires hospitalization may be eligible. They must have certain symptom scores and have stopped other psychotropic medications recently. Please review eligibility criteria for more details.

Is there any cost to participate in this Bipolar-I disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered during participation.

Actively Recruiting

Phase 3

Age: 18Years - 65Years

All Genders

ID06951711

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)

Led by Bristol-Myers Squibb · Updated on 2026-06-04

274

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of KarXT in adults aged 18 to 65 with Bipolar-I disorder who are experiencing an acute manic episode or mania with mixed features. This Phase 3, randomized, double-blind, placebo-controlled inpatient study aims to evaluate how well KarXT works compared to a placebo in improving manic symptoms over a 3-week treatment period. The study includes a screening phase, the inpatient treatment phase, and a safety follow-up, lasting up to seven weeks in total. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. The study compares these two groups to assess the effects on mania symptoms, with careful monitoring throughout the hospitalization. The double-blind design ensures that neither participants nor researchers know who is receiving KarXT or placebo, helping to fairly evaluate the treatment's impact. During the study, participants will be assessed using tools such as the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Bipolar (CGI-BP) scale at baseline and after three weeks. Researchers will monitor symptom changes, response rates, and safety throughout the study. The total participation time includes screening, treatment, and follow-up, lasting no more than seven weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have a primary diagnosis of Bipolar-I disorder confirmed by psychiatric evaluation.
Participants must be experiencing an acute episode or relapse of mania or mania with mixed features lasting 3 weeks or less.
Participants must require hospitalization for the acute mania episode.
Participants must have discontinued all psychotropic medications within 14 days before the first dose.
Participants must have a Young Mania Rating Scale (YMRS) score of 20 or more at screening and baseline.
Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) score of 4 or more at screening and baseline.

You will not qualify if you...

Participants with any primary DSM-5-TR disorder other than Bipolar-I with mania or mania with mixed features within 12 months before screening are excluded.
Participants with Bipolar-I disorder with rapid cycling (4 or more mood episodes in one year) are excluded.
Participants with moderate to severe substance use disorder (except tobacco) within 12 months before screening are excluded.
Participants assessed at risk for suicidal behavior at screening or baseline are excluded.
Participants with cirrhosis, liver cancer, or significant liver disease based on tests are excluded.
Other protocol-defined inclusion and exclusion criteria apply.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants receive flexible dosing of KarXT or placebo to treat manic episodes in Bipolar-I Disorder.

Weekly visits for up to 3 weeks

Trial Site Locations

Total: 78 locations

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States, 72204

Actively Recruiting

Woodland Research Northwest

Rogers, Arkansas, United States, 72758

Actively Recruiting

Proscience Research Group

Culver City, California, United States, 90230

Actively Recruiting

Clinical Innovations, Inc. dba CITrials

Riverside, California, United States, 92506

Actively Recruiting

Collaborative Neuroscience Research, LLC

Torrance, California, United States, 90502

Actively Recruiting

Local Institution - 0036

Hialeah Gardens, Florida, United States, 33016

Withdrawn

Behavioral Clinical Research

Hollywood, Florida, United States, 33021

Actively Recruiting

LCC Medical Research Institute

Miami, Florida, United States, 33126

Actively Recruiting

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States, 33016

Actively Recruiting

South Florida Research Phase I-IV

Miami Springs, Florida, United States, 33166

Actively Recruiting

Local Institution - 0019

Tampa, Florida, United States, 33618

Withdrawn

Health Synergy Clinical Research

West Palm Beach, Florida, United States, 33407

Actively Recruiting

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Actively Recruiting

CenExel iResearch, LLC

Decatur, Georgia, United States, 30030

Actively Recruiting

Local Institution - 0020

Chicago, Illinois, United States, 60640

Not Yet Recruiting

CBH Health

Gaithersburg, Maryland, United States, 20877

Actively Recruiting

Precise Research Centers

Flowood, Mississippi, United States, 39232

Actively Recruiting

Arch Clinical Trials

St Louis, Missouri, United States, 63141

Actively Recruiting

Local Institution - 0076

North Las Vegas, Nevada, United States, 89030

Withdrawn

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States, 08053

Actively Recruiting

Local Institution - 0031

Marlton, New Jersey, United States, 08053

Withdrawn

Local Institution - 0075

Charlotte, North Carolina, United States, 28211

Withdrawn

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States, 44720

Actively Recruiting

InSite Clinical Research

DeSoto, Texas, United States, 75115

Actively Recruiting

Local Institution - 0028

Houston, Texas, United States, 77021

Withdrawn

Local Institution - 0095

Richardson, Texas, United States, 75080

Not Yet Recruiting

Pillar Clinical Research - Richardson

Richardson, Texas, United States, 75080

Actively Recruiting

Local Institution - 0009

Zagreb, City of Zagreb, Croatia, 10090

Withdrawn

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia, 10090

Actively Recruiting

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia, 10090

Actively Recruiting

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia, 10090

Actively Recruiting

Psihijatrijska bolnica "Sveti Ivan"

Zagreb, Croatia, 10090

Actively Recruiting

Local Institution - 0065

Vadodara, Gujarat, India, 390021

Not Yet Recruiting

Local Institution - 0082

Belagavi, Karnataka, India, 590010

Not Yet Recruiting

Chethana Center for Neuropsychiatry

Kozhikode, Kerala, India, 673009

Actively Recruiting

Local Institution - 0051

Ludhiana, Punjab, India, 141001

Not Yet Recruiting

Asha Hospital - Hyderabad

Hyderabad, Telangana, India, 500034

Actively Recruiting

Local Institution - 0055

Hyderabad, Telangana, India, 500082

Not Yet Recruiting

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, India, 700014

Actively Recruiting

Local Institution - 0096

Kolkata, West Bengal, India, 700025

Not Yet Recruiting

Shalvata Mental Health Center

Hod HaSharon, Central District, Israel, 4534708

Actively Recruiting

Ness Ziona Mental Health Center

Ness Ziona, Central District, Israel, 7410001

Actively Recruiting

Local Institution - 0058

Petah Tikva, Central District, Israel, 4910002

Not Yet Recruiting

Sheba Medical Center

Ramat Gan, Central District, Israel, 5265601

Actively Recruiting

Be'er Sheva Mental Health Center

Beersheba, Southern District, Israel, 8461144

Actively Recruiting

Kfar Shaul Mental Health Center

Jerusalem, Israel, 9546105

Actively Recruiting

Local Institution - 0001

Milan, Lombardy, Italy, 20122

Withdrawn

Local Institution - 0056

Pisa, Tuscany, Italy, 56126

Withdrawn

Local Institution - 0007

Siena, Tuscany, Italy, 53100

Withdrawn

Local Institution - 0041

Ancona, Italy, 60126

Withdrawn

Local Institution - 0040

Genova, Italy, 16132

Withdrawn

Prof. Dr. Alexandru Obregia Psychiatry Hospital