Skip to content
Bored Studies
RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06951711

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
274
US sites recruiting
21
Study start
June 13, 2025
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: KarXT; Placebo

Conditions: Bipolar Disorder Type I With Mania or Mania With Mixed Features

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Pillar Clinical Research- Little Rock

    Little Rock, AR 72204

    Site contact: Leslie Smith, Site 0014 · 501-350-3285

  • Woodland Research Northwest

    Rogers, AR 72758

    Site contact: Robert Billingsley, Site 0025 · 479-927-3000

  • Proscience Research Group

    Culver City, CA 90230

    Site contact: Marina Bussel, Site 0021 · 424-227-8127

  • Clinical Innovations, Inc. dba CITrials

    Riverside, CA 92506

    Site contact: Evagelos Coskinas, Site 0018 · 951300492

  • Collaborative Neuroscience Research, LLC

    Torrance, CA 90502

    Site contact: Lara Shirikjian, Site 0074 · 310-523-4200

  • Health Synergy Clinical Research

    Boynton Beach, FL 33426

    Site contact: Mohammad Nisar, Site 0083 · 786-831-7303

  • Behavioral Clinical Research

    Hollywood, FL 33021

    Site contact: Olga Lapeyra, Site 0032 · 954-375-7794

  • LCC Medical Research Institute

    Miami, FL 33126

    Site contact: Yesenia Kuan, Site 0026 · 305-400-0814

  • Innovative Clinical Research, Inc.

    Miami Lakes, FL 33016

    Site contact: Rishi Kakar, Site 0081 · 786-512-4106

  • South Florida Research Phase I-IV

    Miami Springs, FL 33166

    Site contact: Silvia Silva Duluc, Site 0015 · 305-669-6166

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron, Site 0022 · 404-881-5800

  • CenExel iResearch, LLC

    Decatur, GA 30030

    Site contact: Kimball Johnson, Site 0016 · 404-537-1281

  • CBH Health

    Gaithersburg, MD 20877

    Site contact: Elia Acevedo Diaz, Site 0024 · 301-251-4702

  • Precise Research Centers

    Flowood, MS 39232

    Site contact: Joseph Kwentus, Site 0017 · 601-420-5810

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: Junaid Syed, Site 0023 · 314-771-6387

  • Hassman Research Institute Marlton Site

    Marlton, NJ 08053

    Site contact: Elan Cohen, Site 0080 · 267-981-8911

  • University of Cincinnati Medical Center

    Cincinnati, OH 45219

    Site contact: Caleb Adler, Site 0029 · 513-404-0279

  • Neuro-Behavioral Clinical Research

    North Canton, OH 44720

    Site contact: Shishuka Malhotra, Site 0038 · 330-493-1118

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Rajinder Shiwach, Site 0012 · 972-283-6286

  • Pillar Clinical Research - Richardson

    Richardson, TX 75080

    Site contact: Scott Bartley, Site 0037 · 214-396-4844

  • Pillar Clinical Research

    Richardson, TX 75080

    Site contact: Fayz Hudefi, Site 0095 · 479-367-2688

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
All mental health studies in Arkansas →
A Study to Evaluate the Efficacy and Safety of KarXT for the… (NCT06951711) | Bored Studies