Actively Recruiting
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Led by Bristol-Myers Squibb · Updated on 2026-04-14
274
Participants Needed
63
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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/Exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 63 locations
1
Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Advanced Research Center Inc.
Anaheim, California, United States, 92805
Actively Recruiting
4
CITrials
Bellflower, California, United States, 90706
Actively Recruiting
5
Local Institution - 0014
Cerritos, California, United States, 90703
Not Yet Recruiting
6
Collaborative Neuroscience Research, LLC
Long Beach, California, United States, 90806
Actively Recruiting
7
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Actively Recruiting
8
NRC Research Institute
Orange, California, United States, 92868
Actively Recruiting
9
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
10
Research Centers of America ( Hollywood )
Hollywood, Florida, United States, 33024
Actively Recruiting
11
Advanced Research Institute of Miami
Homestead, Florida, United States, 33033
Actively Recruiting
12
South Florida Research Phase I-IV
Miami, Florida, United States, 33166
Actively Recruiting
13
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States, 33016
Actively Recruiting
14
Local Institution - 0015
Miami Lakes, Florida, United States, 33016
Not Yet Recruiting
15
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
16
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States, 30328
Actively Recruiting
17
CenExel iResearch, LLC
Savannah, Georgia, United States, 31405
Actively Recruiting
18
Pillar Clinical Research -Chicago
Chicago, Illinois, United States, 60641
Actively Recruiting
19
Richmond Behavioral Associates
Staten Island, New York, United States, 10314
Actively Recruiting
20
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
21
Local Institution - 0029
Irving, Texas, United States, 75062
Withdrawn
22
Pillar Clinical Research - Richardson
Richardson, Texas, United States, 75080
Actively Recruiting
23
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina, C1199ABB
Actively Recruiting
24
Sanatorio Morra S.A.
Córdoba, Argentina, 5000
Actively Recruiting
25
Local Institution - 0108
Mendoza, Argentina, 5502
Not Yet Recruiting
26
Local Institution - 0109
Mendoza, Argentina, 5502
Not Yet Recruiting
27
Ramsay Clinic Northside
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
28
Ramsay Clinic New Farm
Brisbane, Queensland, Australia, 4005
Actively Recruiting
29
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, Bulgaria, 8001
Actively Recruiting
30
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, Bulgaria, 1282
Actively Recruiting
31
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, Bulgaria, 5800
Actively Recruiting
32
MHAT "Dr. Ival Seliminski"
Sliven, Bulgaria, 8800
Actively Recruiting
33
Mental Health Center - Vratsa
Vratsa, Bulgaria, 3000
Actively Recruiting
34
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
35
Local Institution - 0114
Budapest, Hungary, 0
Not Yet Recruiting
36
Semmelweis Egyetem
Budapest, Hungary, 1083
Actively Recruiting
37
Hotei Hospital
Kōnan, Aichi-ken, Japan, 4838248
Actively Recruiting
38
Okehazama Hospital
Toyoake, Aichi-ken, Japan, 470-1168
Actively Recruiting
39
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan, 272-8516
Actively Recruiting
40
Local Institution - 0100
Kitakyushu, Fukuoka, Japan, 803-0831
Withdrawn
41
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan, 080-0024
Actively Recruiting
42
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan, 002-8029
Actively Recruiting
43
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan, 570-8507
Actively Recruiting
44
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan, 847-0031
Actively Recruiting
45
Local Institution - 0081
Iruma, Saitama, Japan, 350-0495
Withdrawn
46
Saitama Konan Hospital
Kumagaya, Saitama, Japan, 360-0114
Actively Recruiting
47
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Actively Recruiting
48
Narimasu Kosei Hospital
tabashi City, Tokyo, Japan, 175-0091
Actively Recruiting
49
Kuramitsu Hospital
Fukuoka, Japan, 819-0037
Actively Recruiting
50
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Japan, 880-8510
Actively Recruiting
51
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
52
Local Institution - 0084
Osaka, Japan, 590-0018
Not Yet Recruiting
53
Showa Medical University Karasuyama Hospital
Tokyo, Japan, 157-8577
Actively Recruiting
54
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
55
Yamagata Sakuracho Hospital
Yamagata, Japan, 990-0045
Actively Recruiting
56
North Shore Hospital
Auckland, New Zealand, 0622
Actively Recruiting
57
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, Poland, 61-485
Actively Recruiting
58
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, Poland, 02-957
Actively Recruiting
59
Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland, 15-272
Actively Recruiting
60
Local Institution - 0111
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Not Yet Recruiting
61
M2M Med
Rybnik, Silesian Voivodeship, Poland, 44-200
Actively Recruiting
62
Local Institution - 0102
Sosnowiec, Silesian Voivodeship, Poland, 41-200
Not Yet Recruiting
63
Clinica Inventiva
Tuszyn, Poland, 95-080
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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