Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Recruiting now Phase 3 NCT03817502
Run by Gedeon Richter Plc. · for 13 to 17 · All sexes
What this study is about
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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).
🚫 You may not be able to join if…
- 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.
Where this trial is running
- ProScience Research Group, Culver City, California, United States
- Atlanta Center for Medical Research, Atlanta, Georgia, United States
- Atlanta Behavioral Research, LLC, Atlanta, Georgia, United States
- Bloomfield Hills MI, Bloomfield Hills, Michigan, United States
- Precise Research Centers, Flowood, Mississippi, United States
- UB Department of Psychiatry, Buffalo, New York, United States
- Manhattan Behavioral Medicine PLLC, New York, New York, United States
- University of Cincinnati, Cincinnati, Ohio, United States
- Family Psychiatry of The Woodlands, The Woodlands, Texas, United States
- Clinic of Child Psychiatry St. Nikolas, Sofia, Bulgaria
- MHAT Targovishte, Targovishte, Bulgaria
- Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS., Barranquilla, Colombia
+ 45 more sites.
Who to contact
Balázs Lázár · +36 1 432 6437 · RA.ctaRichter@richter.hu
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03817502.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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