NCT06951711From ClinicalTrials.govRecruiting

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)

Bipolar Disorder Type I With Mania or Mania With Mixed Features

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Bristol-Myers Squibb
Enrolment target: 274
Started: 13 June 2025
Main results due: 2 November 2026
Study sites: 85
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 65 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(85)

Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Recruiting
Woodland Research Northwest
Rogers, Arkansas, United States
Recruiting
Proscience Research Group
Culver City, California, United States
Recruiting
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States
Recruiting
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Recruiting
Local Institution - 0036
Hialeah Gardens, Florida, United States
Withdrawn
Behavioral Clinical Research
Hollywood, Florida, United States
Recruiting
LCC Medical Research Institute
Miami, Florida, United States
Recruiting
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States
Recruiting
South Florida Research Phase I-IV
Miami Springs, Florida, United States
Recruiting
Local Institution - 0019
Tampa, Florida, United States
Withdrawn
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Recruiting
CenExel iResearch, LLC
Decatur, Georgia, United States
Recruiting
Local Institution - 0020
Chicago, Illinois, United States
Not yet recruiting
CBH Health
Gaithersburg, Maryland, United States
Recruiting
Precise Research Centers
Flowood, Mississippi, United States
Recruiting
Arch Clinical Trials
St Louis, Missouri, United States
Recruiting
Local Institution - 0076
North Las Vegas, Nevada, United States
Withdrawn
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States
Recruiting
Local Institution - 0031
Marlton, New Jersey, United States
Withdrawn
Local Institution - 0075
Charlotte, North Carolina, United States
Withdrawn
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
Recruiting
Adams Clinical Dallas
DeSoto, Texas, United States
Recruiting
Local Institution - 0028
Houston, Texas, United States
Withdrawn
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Recruiting
Pillar Clinical Research
Richardson, Texas, United States
Recruiting
Local Institution - 0103
Beijing, Beijing Municipality, China
Not yet recruiting
Local Institution - 0106
Beijing, Beijing Municipality, China
Not yet recruiting
Local Institution - 0108
Wuhan, Hubei, China
Not yet recruiting
Local Institution - 0107
Changsha, Hunan, China
Not yet recruiting
Local Institution - 0105
Jining Shi, Shandong, China
Not yet recruiting
Local Institution - 0104
Tianjin, Tianjin Municipality, China
Not yet recruiting
Local Institution - 0009
Zagreb, City of Zagreb, Croatia
Withdrawn
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia
Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia
Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia
Recruiting
Psihijatrijska bolnica "Sveti Ivan"
Zagreb, Croatia
Recruiting
GMERS Medical College and General Hospital
Vadodara, Gujarat, India
Recruiting
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, Karnataka, India
Recruiting
Chethana Center for Neuropsychiatry
Kozhikode, Kerala, India
Recruiting
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
Recruiting
Asha Hospital - Hyderabad
Hyderabad, Telangana, India
Recruiting
Local Institution - 0055
Hyderabad, Telangana, India
Not yet recruiting
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, India
Recruiting
Local Institution - 0096
Kolkata, West Bengal, India
Not yet recruiting
Shalvata Mental Health Center
Hod HaSharon, Central District, Israel
Recruiting
Ness Ziona Mental Health Center
Ness Ziona, Central District, Israel
Recruiting
Local Institution - 0058
Petah Tikva, Central District, Israel
Not yet recruiting
Sheba Medical Center
Ramat Gan, Central District, Israel
Recruiting
Be'er Sheva Mental Health Center
Beersheba, Southern District, Israel
Recruiting
Kfar Shaul Mental Health Center
Jerusalem, Israel
Recruiting
Local Institution - 0001
Milan, Lombardy, Italy
Withdrawn
Local Institution - 0056
Pisa, Tuscany, Italy
Withdrawn
Local Institution - 0007
Siena, Tuscany, Italy
Withdrawn
Local Institution - 0041
Ancona, Italy
Withdrawn
Local Institution - 0040
Genova, Italy
Withdrawn
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania
Recruiting

Showing 60 of 85 sites — filter to narrow it down. 49 of the 85 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06951711. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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