A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:
• Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).
• PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
• Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).
Locations
United States
California
Advanced Research Center Inc.
RECRUITING
Anaheim
Inland Psychiatric Medical Group.
RECRUITING
Chino
Proscience Research Group
RECRUITING
Culver City
UCSF Neurosciences Clinical Research Unit (NCRU)
RECRUITING
San Francisco
Florida
Local Institution - 0119
NOT_YET_RECRUITING
Hollywood
Apg Research, Llc
RECRUITING
Orlando
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
Salveo Integrative Health - Lawrenceville
RECRUITING
Lawrenceville
Denali Health Atlanta, LLC
RECRUITING
Stone Mountain
Illinois
EmVenio Research Center - Prime Healthcare
RECRUITING
Chicago
Local Institution - 0122
NOT_YET_RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Local Institution - 0059
NOT_YET_RECRUITING
Worcester
New York
Local Institution - 0061
NOT_YET_RECRUITING
Great Neck
Ohio
University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience
RECRUITING
Cincinnati
Tennessee
Local Institution - 0113
NOT_YET_RECRUITING
Nashville
Texas
VAST Clinical Research
RECRUITING
Garland
Local Institution - 0120
NOT_YET_RECRUITING
Houston
Local Institution - 0066
NOT_YET_RECRUITING
Spring
Virginia
Local Institution - 0050
NOT_YET_RECRUITING
Richmond
Other Locations
Colombia
Local Institution - 0001
NOT_YET_RECRUITING
Barranquilla
Local Institution - 0109
NOT_YET_RECRUITING
Bello
Local Institution - 0020
NOT_YET_RECRUITING
Bogotá
Local Institution - 0009
NOT_YET_RECRUITING
Pereira
Japan
Local Institution - 0086
NOT_YET_RECRUITING
Bunkyo-ku
Local Institution - 0075
NOT_YET_RECRUITING
Chikugo-shi
Local Institution - 0062
NOT_YET_RECRUITING
Miyakonojō
Local Institution - 0056
NOT_YET_RECRUITING
Ōta-ku
Goryokai Medical Corporation - Goryokai Hospital
RECRUITING
Sapporo
Local Institution - 0063
NOT_YET_RECRUITING
Yokohama, Kanagawa
Local Institution - 0025
NOT_YET_RECRUITING
Zentsujichó
Romania
Cabinet Medical Individual Dr Gheorghita Karina Lidia
RECRUITING
Bucharest
Clinica Animedica Bucuresti
RECRUITING
Bucharest
Local Institution - 0029
NOT_YET_RECRUITING
Bucharest
Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry
RECRUITING
Cluj-napoca
Local Institution - 0008
NOT_YET_RECRUITING
Iași
Local Institution - 0030
NOT_YET_RECRUITING
Sibiu
Emergency Clinical Hospital For Children Louis Turcanu Timis
RECRUITING
Timișoara
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2029-12-18
Participants
Target number of participants: 166
Treatments
Experimental: KarXT
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb