Actively Recruiting
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
Led by Bristol-Myers Squibb · Updated on 2025-12-22
48
Participants Needed
8
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia
CONDITIONS
Official Title
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a primary diagnosis of schizophrenia confirmed by psychiatric evaluation using DSM-5-TR criteria and MINI version 7.0.2
- Participants must have a PANSS total score of 80 or less and a CGI-S score of 4 or less at both screening and baseline
- Participants must have a body mass index between 18 and 40 kg/m2
- Participants must be willing and able to discontinue all antipsychotic medications before baseline and comply with all protocol requirements
You will not qualify if you...
- Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia
- Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months such as major depressive disorder or bipolar disorder
- Participants must not have a history of alcohol or drug use disorder within the past 12 months or any clinically significant disease that would affect safety or study results
- Participants must not be at risk for suicidal behavior
- Female participants must not be pregnant or breastfeeding
- 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: 8 locations
1
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720-3118
Actively Recruiting
2
Research Centers of America ( Hollywood )
Hollywood, Florida, United States, 33024
Actively Recruiting
3
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States, 33016
Actively Recruiting
4
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
5
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
6
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
7
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
8
Community Clinical Research
Austin, Texas, United States, 78754
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain the NCT# and Site#
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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