Tests cariprazine in teenagers with schizophrenia
Tests cariprazine against placebo in teenagers aged 13 to 17 with schizophrenia.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Key facts
- Where
- Ivano-Frankivsk, Kharkiv, Kherson, Kyiv, Lviv, Odesa, and Vinnytsia, UkraineSee the 8 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 13 and 17 years old?
Source: NCT03817502, who can take part
Where in Ukraine
- Regional Psychonevrological Hospital #3Ivano-Frankivsk, UkraineNo longer taking part
- SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"Kharkiv, UkraineNo longer taking part
- State Institution "Institute of Health Care for Children and Adolescents of the AMS of UkraineKharkiv, UkraineNo longer taking part
- Kherson Regional Institution of Mental CareKherson, UkraineNo longer taking part
- SI Research Institute of Psychiatry of MoH of UkraineKyiv, UkraineNo longer taking part
- Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric HospitalLviv, UkraineNo longer taking part
- Odesa Regional Medical Centre of Mental HealthOdesa, UkraineNo longer taking part
- Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"Vinnytsia, UkraineNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gedeon Richter Plc.
- Trial code
- NCT03817502EU 2024-513194-44-00
- Record updated
- 8 October 2025
- Original description
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.Read full original descriptionShow less
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
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Inclusion: 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: 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; 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).