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

NCT03817502 · tracked via the Priya Life Science USA tracker

Sponsor

Gedeon Richter Plc.

Phase

Phase 3

Started

2019-06-06

Last updated

2025-10-08

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Cariprazine →Placebo

Cariprazine: Cariprazine capsules, oral administration, once daily.

Placebo: Matching placebo capsules, oral administration, once daily.

Study summary

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

Eligibility

Sex

ALL

Min age

13 Years

Max age

17 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline in PANSS total score at Week 6 — Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.

Trial sites (57)

Facility	City	Region	Status
ProScience Research Group	Culver City	California	Completed
Atlanta Center for Medical Research	Atlanta	Georgia	Completed
Atlanta Behavioral Research, LLC	Atlanta	Georgia	Withdrawn
Bloomfield Hills MI	Bloomfield Hills	Michigan	Withdrawn
Precise Research Centers	Flowood	Mississippi	Withdrawn
UB Department of Psychiatry	Buffalo	New York	Withdrawn
Manhattan Behavioral Medicine PLLC	New York	New York	Withdrawn
University of Cincinnati	Cincinnati	Ohio	Completed
Family Psychiatry of The Woodlands	The Woodlands	Texas	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
E.S.E. Hospital Mental de Antioquia	Bello	Colombia	Suspended
Centro de Investigacion del Sitema Nervioso CISNE	Bogotá	Colombia	Suspended
Instituto Colombiano Sistema Nervioso Clinica Monserrat	Bogotá	Colombia	Suspended
Psynapsis Salud Mental SA	Pereira	Colombia	Suspended
Centro para la Medicina y de Asistencia Medica Especializada S.C.	Culiacán	Mexico	Suspended
Instituto de Investigacion Clinica AC	Durango	Mexico	Suspended
Consultorio de Medicina Especializada del Sector Privado	Guadalajara	Mexico	Withdrawn
Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra	Guanajuato City	Mexico	Suspended
Medical Care and Research S.A. de C.V.	Mérida	Mexico	Active Not Recruiting
Iecsi S.C.	Monterrey	Mexico	Suspended
CIT Neuropsique	Monterrey	Mexico	Suspended
Instituto de Informacion e Investigacion en Salud Mental AC	Monterrey	Mexico	Suspended
BLIND Investigaciones SC	San Luis Potosí City	Mexico	Suspended
Socola Psychiatric Institute Iasi	Iași	Romania	Withdrawn
Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti	Timișoara	Romania	Recruiting
State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"	Arkhangelsk	Russia	Terminated
Kazan State Medical University KSMU	Kazan'	Russia	Suspended
SBHI Specialized Clinical Psychiatric Hospital 1	Krasnodar	Russia	Terminated
Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"	Lipetsk	Russia	Terminated
Joint-Stock Company Scientific Centre of Personalized Medicine	Moscow	Russia	Terminated
SBHI of Moscow Region "Central Clinical Psychiatric Hospital"	Moscow	Russia	Terminated
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod	Nizhny Novgorod	Russia	Terminated
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary	Roshchino	Russia	Terminated
Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko	Saint Petersburg	Russia	Terminated
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation	Saint Petersburg	Russia	Terminated
Center for Medical Rehabilitation named after S.S. Mnukhin	Saint Petersburg	Russia	Terminated
City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova	Saint Petersburg	Russia	Terminated
GBUZ Samara Regional Clinical Psychiatric Hospital	Samara	Russia	Suspended

+ 17 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03817502 on ClinicalTrials.gov ↗ ← All trials in the USA