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

NCT03817502 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: RGH-MD-202018-004006-26
• Study Type: interventional
• Target: 330
• Locations: 8 countries
• Sites: 57

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in PANSS total score at 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.

  Baseline to Week 6

Study Arms (3)

Cariprazine 1.5 mg/d

EXPERIMENTAL

Cariprazine capsules, oral administration, once daily.

Drug: Cariprazine

Cariprazine 4.5 mg/d

EXPERIMENTAL

Cariprazine capsules, oral administration, once daily.

Drug: Cariprazine

Placebo

PLACEBO COMPARATOR

Matching placebo capsules, oral administration, once daily.

Drug: Placebo

Interventions

Cariprazine DRUG

Cariprazine capsules, oral administration, once daily.

Cariprazine 1.5 mg/d; Cariprazine 4.5 mg/d

Placebo DRUG

Matching placebo capsules, oral administration, once daily.

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Gedeon Richter Plc.: lead

Study Sites (57)

ProScience Research Group

Culver City, California, 90230, United States

COMPLETED

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

COMPLETED

Atlanta Behavioral Research, LLC

Atlanta, Georgia, 30338, United States

WITHDRAWN

Bloomfield Hills MI

Bloomfield Hills, Michigan, 48302, United States

WITHDRAWN

Precise Research Centers

Flowood, Mississippi, 39232, United States

WITHDRAWN

UB Department of Psychiatry

Buffalo, New York, 142515, United States

WITHDRAWN

Manhattan Behavioral Medicine PLLC

New York, New York, 10036, United States

WITHDRAWN

University of Cincinnati

Cincinnati, Ohio, 45219, United States

COMPLETED

Family Psychiatry of The Woodlands

The Woodlands, Texas, 77381, United States

COMPLETED

Clinic of Child Psychiatry St. Nikolas

Sofia, 1431, Bulgaria

RECRUITING

MHAT Targovishte

Targovishte, 7700, Bulgaria

RECRUITING

Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.

Barranquilla, 080020, Colombia

SUSPENDED

E.S.E. Hospital Mental de Antioquia

Bello, 051053, Colombia

SUSPENDED

Centro de Investigacion del Sitema Nervioso CISNE

Bogotá, 1111666, Colombia

SUSPENDED

Instituto Colombiano Sistema Nervioso Clinica Monserrat

Bogotá, 250051, Colombia

SUSPENDED

Psynapsis Salud Mental SA

Pereira, 660003, Colombia

SUSPENDED

Centro para la Medicina y de Asistencia Medica Especializada S.C.

Culiacán, 80230, Mexico

SUSPENDED

Instituto de Investigacion Clinica AC

Durango, 34000, Mexico

SUSPENDED

Consultorio de Medicina Especializada del Sector Privado

Guadalajara, 44690, Mexico

WITHDRAWN

Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra

Guanajuato City, 37000, Mexico

SUSPENDED

Medical Care and Research S.A. de C.V.

Mérida, 97070, Mexico

ACTIVE NOT RECRUITING

Iecsi S.C.

Monterrey, 64310, Mexico

SUSPENDED

CIT Neuropsique

Monterrey, 64610, Mexico

SUSPENDED

Instituto de Informacion e Investigacion en Salud Mental AC

Monterrey, 64710, Mexico

SUSPENDED

BLIND Investigaciones SC

San Luis Potosí City, 78213, Mexico

SUSPENDED

Socola Psychiatric Institute Iasi

Iași, 700282, Romania

WITHDRAWN

Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti

Timișoara, 300230, Romania

RECRUITING

State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"

Arkhangelsk, 163530, Russia

TERMINATED

Kazan State Medical University KSMU

Kazan', 420012, Russia

SUSPENDED

SBHI Specialized Clinical Psychiatric Hospital 1

Krasnodar, 350007, Russia

TERMINATED

Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"

Lipetsk, 399083, Russia

TERMINATED

Joint-Stock Company Scientific Centre of Personalized Medicine

Moscow, 105082, Russia

TERMINATED

SBHI of Moscow Region "Central Clinical Psychiatric Hospital"

Moscow, 127083, Russia

TERMINATED

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod

Nizhny Novgorod, 603155, Russia

TERMINATED

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

Roshchino, 188820, Russia

TERMINATED

Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko

Saint Petersburg, 190121, 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, 192019, Russia

TERMINATED

Center for Medical Rehabilitation named after S.S. Mnukhin

Saint Petersburg, 197022, Russia

TERMINATED

City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova

Saint Petersburg, 197341, Russia

TERMINATED

GBUZ Samara Regional Clinical Psychiatric Hospital

Samara, 443016, Russia

SUSPENDED

State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"

Saratov, 410028, Russia

TERMINATED

Smolensk State Medical University

Smolensk, 214019, Russia

SUSPENDED

LLC Podderzhka

Stavropol, 355038, Russia

TERMINATED

LLC Clinic "Sto Let"

Tomsk, 634014, Russia

TERMINATED

Stavropol Regional Psychiatric hospital #2

Tonnel’nyy, 357034, Russia

TERMINATED

Yaroslavl Regional Psychiatric Hospital

Yaroslavl Region, 634009, Russia

TERMINATED

Clinic.Neuro.Psych.Child.Youth

Belgrade, 11000, Serbia

TERMINATED

Institute for Mental Health

Belgrade, 11000, Serbia

TERMINATED

Clinic for psychiatry, KCV

Novi Sad, 21000, Serbia

RECRUITING

Regional Psychonevrological Hospital #3

Ivano-Frankivsk, 76011, Ukraine

TERMINATED

SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"

Kharkiv, 61068, Ukraine

TERMINATED

State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine

Kharkiv, 61153, Ukraine

TERMINATED

Kherson Regional Institution of Mental Care

Kherson, 73488, Ukraine

TERMINATED

SI Research Institute of Psychiatry of MoH of Ukraine

Kyiv, 04108, Ukraine

TERMINATED

Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital

Lviv, 79021, Ukraine

TERMINATED

Odesa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

TERMINATED

Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"

Vinnytsia, 21018, Ukraine

TERMINATED

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Balázs Lázár

CONTACT

+36 1 432 6437; RA.ctaRichter@richter.hu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 25, 2019
• Study Start: June 6, 2019
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.

Locations

ME (9); RO (2); US (9); BU (2); UA (8); RU (19); CO (5); SE (3)