A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
- Conditions
- Bipolar Disorder Type I With Mania or Mania With Mixed Features
- Interventions
- Other: Placebo
- Registration Number
- NCT06951711
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 274
- 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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KarXT KarXT Flexible dosing Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 ≥ 50% decrease from baseline in YMRS score or total score At week 3 Occurrence of response based on change from baseline ≥ 1 in CGI-BP At week 3
Trial Locations
- Locations (64)
Local Institution - 0056
🇮🇹Pisa, Toscana, Italy
Local Institution - 0007
🇮🇹Siena, Toscana, Italy
Local Institution - 0041
🇮🇹Ancona, Italy
Local Institution - 0040
🇮🇹Genova, Italy
Local Institution - 0074
🇺🇸Torrance, California, United States
Local Institution - 0032
🇺🇸Hollywood, Florida, United States
Local Institution - 0076
🇺🇸North Las Vegas, Nevada, United States
Local Institution - 0075
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0073
🇸🇰Košice, Košický Kraj, Slovakia
Local Institution - 0077
🇸🇪Nacka, Stockholms Län [se-01], Sweden
Local Institution - 0014
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0025
🇺🇸Rogers, Arkansas, United States
Local Institution - 0021
🇺🇸Culver City, California, United States
Local Institution - 0018
🇺🇸Riverside, California, United States
Local Institution - 0036
🇺🇸Hialeah Gardens, Florida, United States
Local Institution - 0015
🇺🇸Miami Springs, Florida, United States
Local Institution - 0026
🇺🇸Miami, Florida, United States
Local Institution - 0019
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0022
🇺🇸Atlanta, Georgia, United States
Local Institution - 0016
🇺🇸Decatur, Georgia, United States
Local Institution - 0020
🇺🇸Chicago, Illinois, United States
Local Institution - 0024
🇺🇸Gaithersburg, Maryland, United States
Local Institution - 0017
🇺🇸Flowood, Mississippi, United States
Local Institution - 0023
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0031
🇺🇸Marlton, New Jersey, United States
Local Institution - 0029
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0038
🇺🇸North Canton, Ohio, United States
Local Institution - 0012
🇺🇸DeSoto, Texas, United States
Local Institution - 0028
🇺🇸Houston, Texas, United States
Local Institution - 0037
🇺🇸Richardson, Texas, United States
Local Institution - 0009
🇭🇷Zagreb, Grad Zagreb, Croatia
Local Institution - 0008
🇭🇷Zagreb, Croatia
Local Institution - 0010
🇭🇷Zagreb, Croatia
Local Institution - 0063
🇭🇷Zagreb, Croatia
Local Institution - 0065
🇮🇳Vadodara, Gujarat, India
Local Institution - 0053
🇮🇳Kozhikode, Kerala, India
Local Institution - 0052
🇮🇳Hyderabad, Telangana, India
Local Institution - 0055
🇮🇳Hyderabad, Telangana, India
Local Institution - 0054
🇮🇳Kolkata, West Bengal, India
Local Institution - 0051
🇮🇳Ludhiana, India
Local Institution - 0066
🇮🇱Be'er Sheva, HaDarom, Israel
Local Institution - 0042
🇮🇱Hod HaSharon, HaMerkaz, Israel
Local Institution - 0046
🇮🇱Ness Ziona, HaMerkaz, Israel
Local Institution - 0058
🇮🇱Petah Tikva, HaMerkaz, Israel
Local Institution - 0011
🇮🇱Ramat Gan, HaMerkaz, Israel
Local Institution - 0045
🇮🇱Jerusalem, Yerushalayim, Israel
Local Institution - 0001
🇮🇹Milano, Lombardia, Italy
Local Institution - 0061
🇷🇴Brașov, Brăila, Romania
Local Institution - 0048
🇷🇴Bucharest, București, Romania
Local Institution - 0049
🇷🇴Bucharest, București, Romania
Local Institution - 0050
🇷🇴Bucharest, București, Romania
Local Institution - 0059
🇷🇴Bucharest, București, Romania
Local Institution - 0060
🇷🇴Bucharest, București, Romania
Local Institution - 0062
🇷🇴Bucharest, București, Romania
Local Institution - 0064
🇷🇴Bucharest, București, Romania
Local Institution - 0057
🇷🇴București, Romania
Local Institution - 0047
🇷🇴Iași, Romania
Local Institution - 0071
🇸🇰Kosice, Košický Kraj, Slovakia
Local Institution - 0072
🇸🇰Vranov nad Topľou, Prešovský Kraj, Slovakia
Local Institution - 0069
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0044
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0039
🇪🇸Bilbo, País Vasco, Spain
Local Institution - 0067
🇸🇪Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0070
🇸🇪Gothenburg, Västra Götalands Län [se-14], Sweden