Bipolar-I Disorder With Mania or Mania With Mixed Features
Conditions
Keywords
Bipolar-I, Mania, Mixed
Brief summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Detailed description
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.
Interventions
DRUGKarXT
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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, borderline personality 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Young Mania Rating Scale (YMRS) score | At week 3 | The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP) | At week 3 | The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, will be used, which includes three components: mania, depression, and overall bipolar illness. The ratings are on a 7-point scale (1 = normal, not ill; 2 = minimally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = very severely ill) |
| Occurrence of response based on a ≥ 50% decrease from baseline in YMRS total score | At week 3 | — |
| Occurrence of response based on CGI-BP change from baseline ≥ 1 | At week 3 | — |
Countries
Argentina, Australia, Bulgaria, Hungary, Japan, New Zealand, Poland, Ukraine, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed