RecruitingPhase 3NCT03817502

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

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

Sponsor

Gedeon Richter Plc.

Enrollment

330 participants

Start Date

Jun 6, 2019

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

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

Min Age: 13 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a medication called cariprazine (an antipsychotic drug already approved for adults) is safe and effective for teenagers aged 13 to 17 who have been diagnosed with schizophrenia — a serious mental health condition that affects how a person thinks, feels, and behaves. **You may be eligible if...** - You are between 13 and 17 years old - You have been diagnosed with schizophrenia according to standard psychiatric guidelines (DSM-5) - Your symptoms (such as hallucinations, delusions, or disorganized thinking) are moderate to severe at the start of the study - Your diagnosis has been confirmed using a structured clinical interview **You may NOT be eligible if...** - You have another diagnosis such as bipolar disorder, schizoaffective disorder, or a psychotic disorder caused by a medical condition or substance - You have intellectual disability (IQ below 70) - You have a history of severe side effects with antipsychotic medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCariprazine

Cariprazine capsules, oral administration, once daily.

DRUGPlacebo

Matching placebo capsules, oral administration, once daily.

Locations(57)

ProScience Research Group

Culver City, California, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States

Bloomfield Hills MI

Bloomfield Hills, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

UB Department of Psychiatry

Buffalo, New York, United States

Manhattan Behavioral Medicine PLLC

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Family Psychiatry of The Woodlands

The Woodlands, Texas, United States

Clinic of Child Psychiatry St. Nikolas

Sofia, Bulgaria

MHAT Targovishte

Targovishte, Bulgaria

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

Psynapsis Salud Mental SA

Pereira, Colombia

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

Culiacán, Mexico

Instituto de Investigacion Clinica AC

Durango, Mexico

Consultorio de Medicina Especializada del Sector Privado

Guadalajara, Mexico

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

Guanajuato City, Mexico

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

Mérida, Mexico

Iecsi S.C.

Monterrey, Mexico

CIT Neuropsique

Monterrey, Mexico

Instituto de Informacion e Investigacion en Salud Mental AC

Monterrey, Mexico

BLIND Investigaciones SC

San Luis Potosí City, Mexico

Socola Psychiatric Institute Iasi

Iași, Romania

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

Timișoara, Romania

State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"

Arkhangelsk, Russia

Kazan State Medical University KSMU

Kazan', Russia

SBHI Specialized Clinical Psychiatric Hospital 1

Krasnodar, Russia

Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"

Lipetsk, Russia

Joint-Stock Company Scientific Centre of Personalized Medicine

Moscow, Russia

SBHI of Moscow Region "Central Clinical Psychiatric Hospital"

Moscow, Russia

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod

Nizhny Novgorod, Russia

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

Roshchino, Russia

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

Saint Petersburg, 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, Russia

Center for Medical Rehabilitation named after S.S. Mnukhin

Saint Petersburg, Russia

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

Saint Petersburg, Russia

GBUZ Samara Regional Clinical Psychiatric Hospital

Samara, Russia

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

Saratov, Russia

Smolensk State Medical University

Smolensk, Russia

LLC Podderzhka

Stavropol, Russia

LLC Clinic "Sto Let"

Tomsk, Russia

Stavropol Regional Psychiatric hospital #2

Tonnel’nyy, Russia

Yaroslavl Regional Psychiatric Hospital

Yaroslavl Region, Russia

Clinic.Neuro.Psych.Child.Youth

Belgrade, Serbia

Institute for Mental Health

Belgrade, Serbia

Clinic for psychiatry, KCV

Novi Sad, Serbia

Regional Psychonevrological Hospital #3

Ivano-Frankivsk, Ukraine

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

Kharkiv, Ukraine

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

Kharkiv, Ukraine

Kherson Regional Institution of Mental Care

Kherson, Ukraine

SI Research Institute of Psychiatry of MoH of Ukraine

Kyiv, Ukraine

Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital

Lviv, Ukraine

Odesa Regional Medical Centre of Mental Health

Odesa, Ukraine

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

Vinnytsia, Ukraine

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NCT03817502

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