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

Launched by BRISTOL-MYERS SQUIBB · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see how effective and safe a new treatment called KarXT is for people experiencing manic episodes due to Bipolar-I Disorder. If you or a loved one has Bipolar-I Disorder and are currently having a manic episode, this study might be an option to consider. Participants need to be between the ages of 65 to 74 or 23 to 740, diagnosed with Bipolar-I Disorder, and have been experiencing mania for less than three weeks. They will also need to be hospitalized for their symptoms and have recently stopped taking other psychiatric medications.

During the trial, participants will receive KarXT and will be closely monitored by medical professionals to evaluate how well it works and if there are any side effects. It's important to note that people with certain other mental health conditions or recent substance use issues cannot participate. The study is not yet recruiting participants, but it aims to provide valuable information about a potential new treatment option for individuals struggling with this condition.

Gender

ALL

Eligibility 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, 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.