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 (41) 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
Local Institution - 0024
NOT_YET_RECRUITING
Culver City
Local Institution - 0083
NOT_YET_RECRUITING
Redlands
Local Institution - 0089
NOT_YET_RECRUITING
San Francisco
Florida
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
Massachusetts
Local Institution - 0076
NOT_YET_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
Local Institution - 0046
NOT_YET_RECRUITING
Garland
Local Institution - 0066
NOT_YET_RECRUITING
Spring
Virginia
Local Institution - 0050
NOT_YET_RECRUITING
Richmond
Other Locations
Argentina
Local Institution - 0036
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0084
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Local Institution - 0035
NOT_YET_RECRUITING
Córdoba
Local Institution - 0085
NOT_YET_RECRUITING
La Plata
Local Institution - 0102
NOT_YET_RECRUITING
Santiago Del Estero
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
Local Institution - 0029
NOT_YET_RECRUITING
Bucharest
Local Institution - 0040
NOT_YET_RECRUITING
Bucharest
Local Institution - 0042
NOT_YET_RECRUITING
Bucharest
Local Institution - 0031
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0008
NOT_YET_RECRUITING
Iași
Local Institution - 0030
NOT_YET_RECRUITING
Sibiu
Local Institution - 0038
NOT_YET_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