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
- Culiacán, Durango, Guadalajara, Guanajuato City, Mérida, Monterrey, and San Luis Potosí City, MexicoSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teenagers aged 13 to 17 with schizophrenia who are moderately ill. It tests cariprazine against a placebo over 6 weeks.
- Age
- 13 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia confirmed by a trained clinician, with a PANSS score of 70 or more and a CGI-S score of 4 or more (moderately ill) at screening and baseline.
Main reasons for not taking part
- Bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Intellectual disability (IQ < 70)
- Any substance-related disorder (except caffeine and tobacco) in the 3 months before Visit 1
Read by machine on 9 November 2026.
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 Mexico
- Centro para la Medicina y de Asistencia Medica Especializada S.C.Culiacán, MexicoNo longer taking part
- Instituto de Investigacion Clinica ACDurango, MexicoNo longer taking part
- Consultorio de Medicina Especializada del Sector PrivadoGuadalajara, MexicoNo longer taking part
- Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la ParraGuanajuato City, MexicoNo longer taking part
- Medical Care and Research S.A. de C.V.Mérida, MexicoNo longer taking part
- CIT NeuropsiqueMonterrey, MexicoNo longer taking part
- Iecsi S.C.Monterrey, MexicoNo longer taking part
- Instituto de Informacion e Investigacion en Salud Mental ACMonterrey, MexicoNo longer taking part
- BLIND Investigaciones SCSan Luis Potosí City, MexicoNo 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).