RECRUITING

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

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Conditions

Bipolar-I Disorder With Mania or Mania With Mixed FeaturesBipolar-IManiaMixed

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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-1)

Quick Facts

Study Start:2025-06-11
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06951698

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 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, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
  2. * Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
  3. * 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.
  4. * 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).
  5. * Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  6. * Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  7. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Study Connect www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site#
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0058
Bentonville, Arkansas, 72712
United States
Local Institution - 0011
Little Rock, Arkansas, 72211
United States
Local Institution - 0005
Anaheim, California, 92805
United States
Local Institution - 0008
Bellflower, California, 90706
United States
Local Institution - 0014
Cerritos, California, 90703
United States
Local Institution - 0059
Long Beach, California, 90806
United States
Local Institution - 0072
Montclair, California, 91763
United States
Local Institution - 0053
Orange, California, 92868
United States
Health Synergy Clinical Research
Boynton Beach, Florida, 33426
United States
Local Institution - 0020
Homestead, Florida, 33033
United States
Local Institution - 0015
Miami Lakes, Florida, 33016
United States
Local Institution - 0054
Miami Lakes, Florida, 33016
United States
Local Institution - 0069
Miami Springs, Florida, 33166
United States
Local Institution - 0009
Atlanta, Georgia, 30328
United States
Local Institution - 0057
Savannah, Georgia, 31405
United States
Local Institution - 0047
Chicago, Illinois, 60641
United States
Local Institution - 0030
Staten Island, New York, 10314
United States
Local Institution - 0013
North Canton, Ohio, 44720
United States
Local Institution - 0029
Irving, Texas, 75062
United States
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2025-06-11
Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

  • Bipolar-I
  • Mania
  • Mixed

Additional Relevant MeSH Terms

  • Bipolar-I Disorder With Mania or Mania With Mixed Features