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RecruitingPhase 3

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Bristol-Myers Squibb · NCT06929273

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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
450
US sites recruiting
40
Study start
July 18, 2025
Record last updated
September 14, 2026

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

What the study is about

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)

The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Being studied: KarXT; Lithium; Valproate; Lamotrigine

Conditions: Bipolar Disorder Type I With Mania

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):

a. Participants must have completed treatment period of parent study.

  • De novo participants who did not participate in double-blind placebo-controlled studies:
  • Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.
  • Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
  • Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
  • Participants does not require hospitalization for acute mania.

Exclusion Criteria

  • All participants:
  • All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.
  • Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):
  • Discontinuation from any KarXT parent studies.
  • De novo participants who did not participate in double-blind placebo-controlled studies:
  • Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
  • Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
  • Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.
  • Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  • Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Recruiting US locations

  • Pillar Clinical Research - Richardson

    Bentonville, AR 72712

    Site contact: Fayz Hudefi, Site 0022 · 479-367-2688

  • Pillar Clinical Research- Little Rock

    Little Rock, AR 72204

    Site contact: Leslie Smith, Site 0021 · 501-350-3285

  • Woodland International Research Group

    Little Rock, AR 72211

    Site contact: George Konis, Site 0038 · 501-221-8681

  • Woodland Research Northwest

    Rogers, AR 72758

    Site contact: Robert Billingsley, Site 0057 · 479-927-3000

  • Advanced Research Center Inc.

    Anaheim, CA 92805

    Site contact: Steven Macina, Site 0027 · 714-999-6688

  • Clinical Innovations, Inc. dba CITrials

    Bellflower, CA 90706

    Site contact: Robert Bota, Site 0050 · 229-815-0219

  • Inland Psychiatric Medical Group - Chino

    Chino, CA 91710

    Site contact: Nandita Puchakayala, Site 0135 · 909-488-9116

  • Proscience Research Group

    Culver City, CA 90230

    Site contact: Marina Bussel, Site 0037 · 424-227-8127

  • Collaborative Neuroscience Research, LLC

    Garden Grove, CA 92845-2506

    Site contact: David Walling, Site 0085 · 714-799-7799

  • Omega Clinical Trials - La Habra

    La Habra, CA 90631

    Site contact: Wakelin McNeel, Site 0137 · 562-690-2200

  • Catalina Research Institute, LLC

    Montclair, CA 91763

    Site contact: Stephen Volk, Site 0056 · 909-590-8409

  • NRC Research Institute

    Orange, CA 92868

    Site contact: Tony Ortiz, Site 0039 · 714-289-1100

  • Clinical Innovations, Inc. dba CITrials

    Riverside, CA 92506

    Site contact: Evagelos Coskinas, Site 0043 · 951300492

  • Collaborative Neuroscience Research, LLC

    Torrance, CA 90504

    Site contact: Lara Shirikjian, Site 0123 · 310-523-4200

  • Yale New Haven Hospital-Smilow Cancer Center

    New Haven, CT 06510

    Site contact: Deepak D'Souza, Site 0131 · 20393257112594

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, FL 33009

    Site contact: Beth Safirstein, Site 0133

  • Behavioral Clinical Research

    Hollywood, FL 33021

    Site contact: Olga Lapeyra, Site 0059 · 954-375-7794

  • Research Centers of America ( Hollywood )

    Hollywood, FL 33024

    Site contact: Edwin Gomez, Site 0053 · 954-604-3900

  • LCC Medical Research Institute

    Miami, FL 33126

    Site contact: Yesenia Kuan, Site 0030 · 305-400-0814

  • Advanced Research Institute of Miami

    Miami, FL 33135

    Site contact: Moraima Trujillo, Site 0028 · 305-246-0001

  • Innovative Clinical Research, Inc.

    Miami Lakes, FL 33016

    Site contact: Rishi Kakar, Site 0047 · 786-512-4106

  • South Florida Research Phase I-IV

    Miami Springs, FL 33166

    Site contact: Silvia Silva Duluc, Site 0025 · 305-669-6166

  • Health Synergy Clinical Research

    West Palm Beach, FL 33407

    Site contact: Mohammad Nisar, Site 0032 · 786-831-7303

  • Synexus Clinical Research US, Inc.

    Atlanta, GA 30328

    Site contact: Bethany Davis, Site 0052 · 404-255-6005

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron, Site 0054 · 404-881-5800

  • CenExel iResearch, LLC

    Decatur, GA 30030

    Site contact: Kimball Johnson, Site 0023 · 404-537-1281

  • CenExel iResearch, LLC

    Savannah, GA 31405

    Site contact: Michael Mobley, Site 0024 · 912-744-0800

  • Pillar Clinical Research -Chicago

    Chicago, IL 60641

    Site contact: Roueen Rafeyan, Site 0020 · 312-865-6336

  • CBH Health

    Gaithersburg, MD 20877

    Site contact: Elia Acevedo Diaz, Site 0049 · 301-251-4702

  • Precise Research Centers

    Flowood, MS 39232

    Site contact: Joseph Kwentus, Site 0029 · 601-420-5810

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: Junaid Syed, Site 0042 · 314-771-6387

  • Hassman Research Institute Marlton Site

    Marlton, NJ 08053

    Site contact: Elan Cohen, Site 0130 · 267-981-8911

  • Richmond Behavioral Associates

    Staten Island, NY 10314

    Site contact: Peter Weiden, Site 0033 · 917-701-7484

  • University of Cincinnati Medical Center

    Cincinnati, OH 45219

    Site contact: Caleb Adler, Site 0055 · 513-404-0279

  • Neuro-Behavioral Clinical Research

    North Canton, OH 44720

    Site contact: Shishuka Malhotra, Site 0040 · 330-493-1118

  • Community Clinical Research

    Austin, TX 78754

    Site contact: David Brown, Site 0134 · 512-323-2622

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Rajinder Shiwach, Site 0048 · 972-283-6286

  • Elevate Clinical Research-Houston

    Houston, TX 77058

    Site contact: Matthews Brams, Site 0138 · 409-331-6040

  • Prime Clinical Research - Mansfield

    Mansfield, TX 76063

    Site contact: Jamie Alexander, Site 0139 · 817-907-7330

  • Pillar Clinical Research - Richardson

    Richardson, TX 75080

    Site contact: Scott Bartley, Site 0034 · 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 Assess the Long-term Safety of KarXT for the Treatment… (NCT06929273) | Bored Studies