A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
- Conditions
- Bipolar-I Disorder With Mania or Mania With Mixed Features
- Interventions
- Other: Placebo
- Registration Number
- NCT06951698
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 274
Not provided
- 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.
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 a ≥ 50% decrease from baseline in YMRS score At week 3 Occurrence of response based on CGI-BP change from baseline ≥ 1 At week 3
Trial Locations
- Locations (61)
Local Institution - 0058
🇺🇸Bentonville, Arkansas, United States
Local Institution - 0011
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0005
🇺🇸Anaheim, California, United States
Local Institution - 0008
🇺🇸Bellflower, California, United States
Local Institution - 0120
🇧🇬Sliven, Bulgaria
Local Institution - 0014
🇺🇸Cerritos, California, United States
Local Institution - 0059
🇺🇸Long Beach, California, United States
Local Institution - 0072
🇺🇸Montclair, California, United States
Local Institution - 0053
🇺🇸Orange, California, United States
Local Institution - 0054
🇺🇸Lauderhill, Florida, United States
Local Institution - 0015
🇺🇸Miami Lakes, Florida, United States
Local Institution - 0069
🇺🇸Miami Springs, Florida, United States
Local Institution - 0020
🇺🇸Miami, Florida, United States
Local Institution - 0023
🇺🇸Stuart, Florida, United States
Local Institution - 0009
🇺🇸Atlanta, Georgia, United States
Local Institution - 0057
🇺🇸Savannah, Georgia, United States
Local Institution - 0047
🇺🇸Chicago, Illinois, United States
Local Institution - 0030
🇺🇸Staten Island, New York, United States
Local Institution - 0013
🇺🇸North Canton, Ohio, United States
Local Institution - 0029
🇺🇸Irving, Texas, United States
Local Institution - 0044
🇺🇸Richardson, Texas, United States
Local Institution - 0110
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0115
🇦🇷Córdoba, Argentina
Local Institution - 0108
🇦🇷Mendoza, Argentina
Local Institution - 0109
🇦🇷Mendoza, Argentina
Local Institution - 0117
🇦🇺St Leonards, New South Wales, Australia
Local Institution - 0106
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0113
🇧🇬Burgas, Bulgaria
Local Institution - 0119
🇧🇬Novi Iskar, Bulgaria
Local Institution - 0112
🇧🇬Pleven, Bulgaria
Local Institution - 0121
🇧🇬Vratsa, Bulgaria
Local Institution - 0116
🇭🇺Győr, Győr-Moson-Sopron, Hungary
Local Institution - 0114
🇭🇺Budapest, Hungary
Local Institution - 0118
🇭🇺Budapest, Hungary
Local Institution - 0082
🇯🇵Konan, Aichi, Japan
Local Institution - 0079
🇯🇵Toyoake, Aichi, Japan
Local Institution - 0078
🇯🇵Ichikawa, Chiba, Japan
Local Institution - 0100
🇯🇵Kitakyushu, Fukuoka, Japan
Local Institution - 0090
🇯🇵Obihiro, Hokkaido, Japan
Local Institution - 0080
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0087
🇯🇵Karatsu-shi, Saga-Ken, Japan
Local Institution - 0081
🇯🇵Iruma, Saitama, Japan
Local Institution - 0092
🇯🇵Kumagaya, Saitama, Japan
Local Institution - 0085
🇯🇵Itabashi City, Tokyo, Japan
Local Institution - 0105
🇯🇵Kodaira, Tokyo, Japan
Local Institution - 0083
🇯🇵Fukuoka, Japan
Local Institution - 0077
🇯🇵Miyazaki, Japan
Local Institution - 0086
🇯🇵Osaka, Japan
Local Institution - 0089
🇯🇵Osaka, Japan
Local Institution - 0084
🇯🇵Osaka, Japan
Local Institution - 0104
🇯🇵Tokyo, Japan
Local Institution - 0076
🇯🇵Wakayama, Japan
Local Institution - 0088
🇯🇵Yamagata, Japan
Local Institution - 0055
🇳🇿Auckland, New Zealand
Local Institution - 0107
🇵🇱Warsaw, Mazowieckie, Poland
Local Institution - 0094
🇵🇱Bialystok, Podlaskie, Poland
Local Institution - 0111
🇵🇱Gdańsk, Pomorskie, Poland
Local Institution - 0095
🇵🇱Poznań, Wielkopolskie, Poland
Local Institution - 0096
🇵🇱Tuszyn, Łódzkie, Poland
Local Institution - 0103
🇵🇱Chorzów, Śląskie, Poland
Local Institution - 0102
🇵🇱Sosnowiec, Śląskie, Poland