Condition: Schizophrenia · Sponsor: Gedeon Richter Plc.
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Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
This description comes directly from the study's public registry record.
Balázs Lázár · +36 1 432 6437 · RA.ctaRichter@richter.hu
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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, 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| ProScience Research Group | Culver City, California, United States | Completed |
| Atlanta Center for Medical Research | Atlanta, Georgia, United States | Completed |
| Atlanta Behavioral Research, LLC | Atlanta, Georgia, United States | Withdrawn |
| Bloomfield Hills MI | Bloomfield Hills, Michigan, United States | Withdrawn |
| Precise Research Centers | Flowood, Mississippi, United States | Withdrawn |
| UB Department of Psychiatry | Buffalo, New York, United States | Withdrawn |
| Manhattan Behavioral Medicine PLLC | New York, New York, United States | Withdrawn |
| University of Cincinnati | Cincinnati, Ohio, United States | Completed |
| Family Psychiatry of The Woodlands | The Woodlands, Texas, United States | Completed |
| Clinic of Child Psychiatry St. Nikolas | Sofia, Bulgaria | Recruiting |
| MHAT Targovishte | Targovishte, Bulgaria | Recruiting |
| Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS. | Barranquilla, Colombia | Suspended |
+ 45 more locations — full list on the registry record.
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