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Study identifier: NCT03817502 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Condition: Schizophrenia  ·  Sponsor: Gedeon Richter Plc.

PhasePhase 3
Planned participants330
Who can joinAll sexes, 13 Years to 17 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where57 locations · 8 countries

Interested? Contact the study team ↓

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.

About this study

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.

Talk to the study team

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.

Full eligibility criteria (exactly as the study team wrote them)

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.

Locations (57)

ProScience Research GroupCulver City, California, United StatesCompleted
Atlanta Center for Medical ResearchAtlanta, Georgia, United StatesCompleted
Atlanta Behavioral Research, LLCAtlanta, Georgia, United StatesWithdrawn
Bloomfield Hills MIBloomfield Hills, Michigan, United StatesWithdrawn
Precise Research CentersFlowood, Mississippi, United StatesWithdrawn
UB Department of PsychiatryBuffalo, New York, United StatesWithdrawn
Manhattan Behavioral Medicine PLLCNew York, New York, United StatesWithdrawn
University of CincinnatiCincinnati, Ohio, United StatesCompleted
Family Psychiatry of The WoodlandsThe Woodlands, Texas, United StatesCompleted
Clinic of Child Psychiatry St. NikolasSofia, BulgariaRecruiting
MHAT TargovishteTargovishte, BulgariaRecruiting
Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.Barranquilla, ColombiaSuspended

+ 45 more locations — full list on the registry record.

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