RecruitingPhase 3NCT03817502
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
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
Sponsor
Gedeon Richter Plc.
Enrollment
330 participants
Start Date
Jun 6, 2019
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 13 YearsMax Age: 17 Years
Inclusion Criteria4
- 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 Criteria3
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Diagnosis of intellectual disability (IQ \< 70).
- Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.
Interventions
DRUGCariprazine
Cariprazine capsules, oral administration, once daily.
DRUGPlacebo
Matching placebo capsules, oral administration, once daily.
Locations(57)
View Full Details on ClinicalTrials.gov
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NCT03817502
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