Actively Recruiting

Phase 3
Age: 13Years - 17Years
All Genders
NCT03817502

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

Led by Gedeon Richter Plc. · Updated on 2025-10-08

330

Participants Needed

57

Research Sites

392 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • DSM-5 primary diagnosis of schizophrenia
  • Schizophrenia diagnosis confirmed by K-SADS-PL at screening by a trained clinician
  • PANSS score of 70 or higher and at least moderate severity (score 64 4) on two or more positive symptom items at screening and baseline
  • CGI-S scale score of 4 or higher (moderately ill) at screening and baseline
Not Eligible

You will not qualify if you...

  • 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 less than 70)
  • History of any substance-related disorder (except caffeine and tobacco) within 3 months before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 57 locations

1

ProScience Research Group

Culver City, California, United States, 90230

Completed

2

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Completed

3

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States, 30338

Withdrawn

4

Bloomfield Hills MI

Bloomfield Hills, Michigan, United States, 48302

Withdrawn

5

Precise Research Centers

Flowood, Mississippi, United States, 39232

Withdrawn

6

UB Department of Psychiatry

Buffalo, New York, United States, 142515

Withdrawn

7

Manhattan Behavioral Medicine PLLC

New York, New York, United States, 10036

Withdrawn

8

University of Cincinnati

Cincinnati, Ohio, United States, 45219

Completed

9

Family Psychiatry of The Woodlands

The Woodlands, Texas, United States, 77381

Completed

10

Clinic of Child Psychiatry St. Nikolas

Sofia, Bulgaria, 1431

Actively Recruiting

11

MHAT Targovishte

Targovishte, Bulgaria, 7700

Actively Recruiting

12

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

Barranquilla, Colombia, 080020

Suspended

13

E.S.E. Hospital Mental de Antioquia

Bello, Colombia, 051053

Suspended

14

Centro de Investigacion del Sitema Nervioso CISNE

Bogotá, Colombia, 1111666

Suspended

15

Instituto Colombiano Sistema Nervioso Clinica Monserrat

Bogotá, Colombia, 250051

Suspended

16

Psynapsis Salud Mental SA

Pereira, Colombia, 660003

Suspended

17

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

Culiacán, Mexico, 80230

Suspended

18

Instituto de Investigacion Clinica AC

Durango, Mexico, 34000

Suspended

19

Consultorio de Medicina Especializada del Sector Privado

Guadalajara, Mexico, 44690

Withdrawn

20

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

Guanajuato City, Mexico, 37000

Suspended

21

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

Mérida, Mexico, 97070

Active, Not Recruiting

22

Iecsi S.C.

Monterrey, Mexico, 64310

Suspended

23

CIT Neuropsique

Monterrey, Mexico, 64610

Suspended

24

Instituto de Informacion e Investigacion en Salud Mental AC

Monterrey, Mexico, 64710

Suspended

25

BLIND Investigaciones SC

San Luis Potosí City, Mexico, 78213

Suspended

26

Socola Psychiatric Institute Iasi

Iași, Romania, 700282

Withdrawn

27

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

Timișoara, Romania, 300230

Actively Recruiting

28

State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"

Arkhangelsk, Russia, 163530

Terminated

29

Kazan State Medical University KSMU

Kazan', Russia, 420012

Suspended

30

SBHI Specialized Clinical Psychiatric Hospital 1

Krasnodar, Russia, 350007

Terminated

31

Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"

Lipetsk, Russia, 399083

Terminated

32

Joint-Stock Company Scientific Centre of Personalized Medicine

Moscow, Russia, 105082

Terminated

33

SBHI of Moscow Region "Central Clinical Psychiatric Hospital"

Moscow, Russia, 127083

Terminated

34

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod

Nizhny Novgorod, Russia, 603155

Terminated

35

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

Roshchino, Russia, 188820

Terminated

36

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

Saint Petersburg, Russia, 190121

Terminated

37

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, 192019

Terminated

38

Center for Medical Rehabilitation named after S.S. Mnukhin

Saint Petersburg, Russia, 197022

Terminated

39

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

Saint Petersburg, Russia, 197341

Terminated

40

GBUZ Samara Regional Clinical Psychiatric Hospital

Samara, Russia, 443016

Suspended

41

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

Saratov, Russia, 410028

Terminated

42

Smolensk State Medical University

Smolensk, Russia, 214019

Suspended

43

LLC Podderzhka

Stavropol, Russia, 355038

Terminated

44

LLC Clinic "Sto Let"

Tomsk, Russia, 634014

Terminated

45

Stavropol Regional Psychiatric hospital #2

Tonnel’nyy, Russia, 357034

Terminated

46

Yaroslavl Regional Psychiatric Hospital

Yaroslavl Region, Russia, 634009

Terminated

47

Clinic.Neuro.Psych.Child.Youth

Belgrade, Serbia, 11000

Terminated

48

Institute for Mental Health

Belgrade, Serbia, 11000

Terminated

49

Clinic for psychiatry, KCV

Novi Sad, Serbia, 21000

Actively Recruiting

50

Regional Psychonevrological Hospital #3

Ivano-Frankivsk, Ukraine, 76011

Terminated

51

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

Kharkiv, Ukraine, 61068

Terminated

52

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

Kharkiv, Ukraine, 61153

Terminated

53

Kherson Regional Institution of Mental Care

Kherson, Ukraine, 73488

Terminated

54

SI Research Institute of Psychiatry of MoH of Ukraine

Kyiv, Ukraine, 04108

Terminated

55

Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital

Lviv, Ukraine, 79021

Terminated

56

Odesa Regional Medical Centre of Mental Health

Odesa, Ukraine, 65006

Terminated

57

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

Vinnytsia, Ukraine, 21018

Terminated

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Research Team

B

Balázs Lázár

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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