Last updated 20 days ago
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
274 patients around the world
Available in Argentina, United States
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient
study in subjects 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.
Bristol-Myers Squibb
274Patients around the world
This study is for people with
Bipolar disorder
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- 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.
- 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.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.
StudyBALSAM-1
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Bipolar disorder
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06951698
