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NCT03817502PHASE3Recruiting

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

Gedeon Richter Plc.

Start Date

6/6/2019

Completion Date

12/15/2026

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 Criteria

Age Range: 13 years to 17 years

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.

Interventions

DRUG

Cariprazine

DRUG

Placebo

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Conditions

Schizophrenia

Locations

ProScience Research Group

Culver City, California 90230

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia 30338

United States

Bloomfield Hills MI

Bloomfield Hills, Michigan 48302

United States

Precise Research Centers

Flowood, Mississippi 39232

United States

UB Department of Psychiatry

Buffalo, New York 142515

United States

Manhattan Behavioral Medicine PLLC

New York, New York 10036

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Family Psychiatry of The Woodlands

The Woodlands, Texas 77381

United States

Clinic of Child Psychiatry St. Nikolas

Sofia, 1431

Bulgaria

MHAT Targovishte

Targovishte, 7700

Bulgaria

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

Barranquilla, 080020

Colombia

E.S.E. Hospital Mental de Antioquia

Bello, 051053

Colombia

Centro de Investigacion del Sitema Nervioso CISNE

Bogotá, 1111666

Colombia

Instituto Colombiano Sistema Nervioso Clinica Monserrat

Bogotá, 250051

Colombia

Psynapsis Salud Mental SA

Pereira, 660003

Colombia

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

Culiacán, 80230

Mexico

Instituto de Investigacion Clinica AC

Durango, 34000

Mexico

Consultorio de Medicina Especializada del Sector Privado

Guadalajara, 44690

Mexico

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

Guanajuato City, 37000

Mexico

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

Mérida, 97070

Mexico

Iecsi S.C.

Monterrey, 64310

Mexico

CIT Neuropsique

Monterrey, 64610

Mexico

Instituto de Informacion e Investigacion en Salud Mental AC

Monterrey, 64710

Mexico

BLIND Investigaciones SC

San Luis Potosí City, 78213

Mexico

Socola Psychiatric Institute Iasi

Iași, 700282

Romania

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

Timișoara, 300230

Romania

State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"

Arkhangelsk, 163530

Russia

Kazan State Medical University KSMU

Kazan', 420012

Russia

SBHI Specialized Clinical Psychiatric Hospital 1

Krasnodar, 350007

Russia

Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"

Lipetsk, 399083

Russia

Joint-Stock Company Scientific Centre of Personalized Medicine

Moscow, 105082

Russia

SBHI of Moscow Region "Central Clinical Psychiatric Hospital"

Moscow, 127083

Russia

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod

Nizhny Novgorod, 603155

Russia

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

Roshchino, 188820

Russia

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

Saint Petersburg, 190121

Russia

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

Center for Medical Rehabilitation named after S.S. Mnukhin

Saint Petersburg, 197022

Russia

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

Saint Petersburg, 197341

Russia

GBUZ Samara Regional Clinical Psychiatric Hospital

Samara, 443016

Russia

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

Saratov, 410028

Russia

Smolensk State Medical University

Smolensk, 214019

Russia

LLC Podderzhka

Stavropol, 355038

Russia

LLC Clinic "Sto Let"

Tomsk, 634014

Russia

Stavropol Regional Psychiatric hospital #2

Tonnel'nyy, 357034

Russia

Yaroslavl Regional Psychiatric Hospital

Yaroslavl Region, 634009

Russia

Clinic.Neuro.Psych.Child.Youth

Belgrade, 11000

Serbia

Institute for Mental Health

Belgrade, 11000

Serbia

Clinic for psychiatry, KCV

Novi Sad, 21000

Serbia

Regional Psychonevrological Hospital #3

Ivano-Frankivsk, 76011

Ukraine

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

Kharkiv, 61068

Ukraine

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

Kharkiv, 61153

Ukraine

Kherson Regional Institution of Mental Care

Kherson, 73488

Ukraine

SI Research Institute of Psychiatry of MoH of Ukraine

Kyiv, 04108

Ukraine

Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital

Lviv, 79021

Ukraine

Odesa Regional Medical Centre of Mental Health

Odesa, 65006

Ukraine

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

Vinnytsia, 21018

Ukraine