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)
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Eligibility
- Age range
- 13–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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). Exclusion Criteria: * Any primary DSM-5-TR disorder other than sc…
Interventions
- DrugKarXT
Specified dose on specified days
- OtherKarXT Matching Placebo
Specified dose on specified days
Locations (44)
- Local Institution - 0077Anaheim, California
- Local Institution - 0058Chino, California
- Local Institution - 0083Redlands, California
- Local Institution - 0089San Francisco, California
- Local Institution - 0032Orlando, Florida
- Atlanta Center for Medical ResearchAtlanta, Georgia