Actively Recruiting
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
Eligibility Criteria
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
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
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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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
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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