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RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06951698

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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
19
Study start
June 11, 2025
Record last updated
October 23, 2026

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

What the study is about

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Being studied: KarXT; Placebo

Conditions: Bipolar-I Disorder 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 a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  • Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Recruiting US locations

  • Woodland International Research Group

    Little Rock, AR 72211

    Site contact: George Konis, Site 0011 · 501-221-8681

  • Advanced Research Center Inc.

    Anaheim, CA 92805

    Site contact: Steven Macina, Site 0005 · 714-999-6688

  • CITrials

    Bellflower, CA 90706

    Site contact: Gerald Maguire, Site 0008 · 562-249-6956

  • Collaborative Neuroscience Research, LLC

    Long Beach, CA 90806

    Site contact: David Walling, Site 0059 · 714-799-7799

  • NRC Research Institute

    Los Angeles, CA 90015

    Site contact: Tony Ortiz, Site 0053 · 714-289-1100

  • Catalina Research Institute, LLC

    Montclair, CA 91763

    Site contact: Stephen Volk, Site 0072 · 909-590-8409

  • Connecticut Mental Health Center

    New Haven, CT 06519

    Site contact: Deepak D'Souza, Site 0124 · 20393257112594

  • Research Centers of America ( Hollywood )

    Hollywood, FL 33024

    Site contact: Edwin Gomez, Site 0043 · 954-604-3900

  • Advanced Research Institute of Miami

    Homestead, FL 33033

    Site contact: Moraima Trujillo, Site 0020 · 305-246-0001

  • South Florida Research Phase I-IV

    Miami, FL 33166

    Site contact: Silvia Silva Duluc, Site 0069 · 305-669-6166

  • Innovative Clinical Research, Inc.

    Miami Lakes, FL 33016

    Site contact: Rishi Kakar, Site 0054 · 786-512-4106

  • Health Synergy Clinical Research

    West Palm Beach, FL 33407

    Site contact: Mohammad Nisar, Site 0023 · 786-831-7303

  • Synexus Clinical Research US, Inc.

    Atlanta, GA 30328

    Site contact: Bethany Davis, Site 0009 · 404-255-6005

  • CenExel iResearch, LLC

    Savannah, GA 31405

    Site contact: Michael Mobley, Site 0057 · 912-744-0800

  • Pillar Clinical Research -Chicago

    Chicago, IL 60641

    Site contact: Roueen Rafeyan, Site 0047 · 312-865-6336

  • Richmond Behavioral Associates

    Staten Island, NY 10314

    Site contact: Peter Weiden, Site 0030 · 917-701-7484

  • Neuro-Behavioral Clinical Research

    North Canton, OH 44720

    Site contact: Shishuka Malhotra, Site 0013 · 330-493-1118

  • Community Clinical Research

    Austin, TX 78754

    Site contact: David Brown, Site 0141 · 512-323-2622

  • Pillar Clinical Research - Richardson

    Richardson, TX 75080

    Site contact: Scott Bartley, Site 0044 · 214-396-4844

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 #.
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A Study to Evaluate the Efficacy and Safety of KarXT for the… (NCT06951698) | Bored Studies