RECRUITING

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

Description

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.

Conditions

Bipolar Disorder Type I With Mania
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Related Conditions:

Bipolar Disorder Type I With Mania

Study Overview

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Study Details

Study overview

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.

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 (BALSAM-3)

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

Condition
Bipolar Disorder Type I With Mania
Intervention / Treatment

-

Contacts and Locations

Glendale

Local Institution - 0120, Glendale, Arizona, United States, 85304

Bentonville

Local Institution - 0022, Bentonville, Arkansas, United States, 72712

Little Rock

Local Institution - 0021, Little Rock, Arkansas, United States, 72204

Little Rock

Local Institution - 0038, Little Rock, Arkansas, United States, 72211

Rogers

Local Institution - 0057, Rogers, Arkansas, United States, 72758

Anaheim

Local Institution - 0027, Anaheim, California, United States, 92805

Bellflower

Local Institution - 0050, Bellflower, California, United States, 90706

Cerritos

Local Institution - 0044, Cerritos, California, United States, 90703

Culver City

Local Institution - 0037, Culver City, California, United States, 90230

Garden Grove

Local Institution - 0085, Garden Grove, California, United States, 92845-2506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):
  • * De novo participants who did not participate in double-blind placebo-controlled studies:
  • 1. 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.
  • 2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
  • 3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
  • 4. Participants does not require hospitalization for acute mania.
  • * Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):
  • * De novo participants who did not participate in double-blind placebo-controlled studies:
  • 1. 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.
  • 2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
  • 3. 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, and primary psychotic disorder, with the exception of mild anxiety disorders.
  • 4. 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.
  • 5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  • 6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  • 7. Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2028-06-13