Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Key facts
- Study ID
- NCT03817502
- Run by
- Gedeon Richter Plc.
- People needed
- 330
- Starts
- 2019-06-06
- Expected to finish
- 2026-12-15
- Last updated by the study team
- 2025-10-08
Who can join
Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- Clinic of Child Psychiatry St. Nikolas — Sofia, Bulgaria (enrolling)
- MHAT Targovishte — Targovishte, Bulgaria (enrolling)
- Clinic for psychiatry, KCV — Novi Sad, Serbia (enrolling)
- Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti — Timișoara, Romania (enrolling)
- UB Department of Psychiatry — Buffalo, New York, United States
- Manhattan Behavioral Medicine PLLC — New York, New York, United States
- Atlanta Behavioral Research, LLC — Atlanta, Georgia, United States
- Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra — Guanajuato City, Mexico
- Precise Research Centers — Flowood, Mississippi, United States
- Iecsi S.C. — Monterrey, Mexico
- Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS. — Barranquilla, Colombia
- E.S.E. Hospital Mental de Antioquia — Bello, Colombia
- Centro de Investigacion del Sitema Nervioso CISNE — Bogotá, Colombia
- Instituto Colombiano Sistema Nervioso Clinica Monserrat — Bogotá, Colombia
- Instituto de Investigacion Clinica AC — Durango, Mexico
- Family Psychiatry of The Woodlands — The Woodlands, Texas, United States
- Centro para la Medicina y de Asistencia Medica Especializada S.C. — Culiacán, Mexico
- Consultorio de Medicina Especializada del Sector Privado — Guadalajara, Mexico
- Psynapsis Salud Mental SA — Pereira, Colombia
- Medical Care and Research S.A. de C.V. — Mérida, Mexico
- University of Cincinnati — Cincinnati, Ohio, United States
- CIT Neuropsique — Monterrey, Mexico
- Instituto de Informacion e Investigacion en Salud Mental AC — Monterrey, Mexico
- BLIND Investigaciones SC — San Luis Potosí City, Mexico
- Bloomfield Hills MI — Bloomfield Hills, Michigan, United States
Full record on ClinicalTrials.gov
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