A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Gedeon Richter Plc.
Summary
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Eligibility
- Age range
- 13–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * DSM-5 primary diagnosis of schizophrenia. * Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician. * PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2). * CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2). Exclusion Criteria: * Current diagnosis of bipolar disorder,…
Interventions
- DrugCariprazine
Cariprazine capsules, oral administration, once daily.
- DrugPlacebo
Matching placebo capsules, oral administration, once daily.
Locations (57)
- ProScience Research GroupCulver City, California
- Atlanta Center for Medical ResearchAtlanta, Georgia
- Atlanta Behavioral Research, LLCAtlanta, Georgia
- Bloomfield Hills MIBloomfield Hills, Michigan
- Precise Research CentersFlowood, Mississippi
- UB Department of PsychiatryBuffalo, New York