NCT03817502RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- First submitted
- 24 Jan 2019
- Start date
- 6 Jun 2019
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- Gedeon Richter Plc.
- Diseases
- Schizophrenia
- NCT number
- NCT03817502
- EU CT number
- 2024-513194-44-00
- EudraCT number
- 2018-004006-26
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 330
- From 6 Jun 2019 to the primary completion date, 15 Dec 2026
- 56 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
Other
- Diagnosis of intellectual disability (IQ \< 70).
Who the study is looking for
- 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).
Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Multiprofile Hospital For Active Treatment - Targovishte AD Coordinator of this site? Confirm its status | Targovishte | Bulgaria | Completed |
| Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS. Coordinator of this site? Confirm its status | Barranquilla | Colombia | Suspended |
| E.S.E. Hospital Mental de Antioquia Coordinator of this site? Confirm its status | Bello | Colombia | Suspended |
| Centro de Investigacion del Sitema Nervioso CISNE Coordinator of this site? Confirm its status | Bogotá | Colombia | Suspended |
| Instituto Colombiano Sistema Nervioso Clinica Monserrat Coordinator of this site? Confirm its status | Bogotá | Colombia | Suspended |
| Psynapsis Salud Mental SA Coordinator of this site? Confirm its status | Pereira | Colombia | Suspended |
| Centro para la Medicina y de Asistencia Medica Especializada S.C. Coordinator of this site? Confirm its status | Culiacán | Mexico | Suspended |
| Instituto de Investigacion Clinica AC Coordinator of this site? Confirm its status | Durango | Mexico | Suspended |
| Consultorio de Medicina Especializada del Sector Privado Coordinator of this site? Confirm its status | Guadalajara | Mexico | Withdrawn |
| Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra Coordinator of this site? Confirm its status | Guanajuato City | Mexico | Suspended |
| Medical Care and Research S.A. de C.V. Coordinator of this site? Confirm its status | Mérida | Mexico | Active, not recruiting |
| CIT Neuropsique Coordinator of this site? Confirm its status | Monterrey | Mexico | Suspended |
| Iecsi S.C. Coordinator of this site? Confirm its status | Monterrey | Mexico | Suspended |
| Instituto de Informacion e Investigacion en Salud Mental AC Coordinator of this site? Confirm its status | Monterrey | Mexico | Suspended |
| BLIND Investigaciones SC Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Suspended |
| Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara Coordinator of this site? Confirm its status | Timișoara | Romania | Completed |
| Institute for Mental Health Coordinator of this site? Confirm its status | Belgrade | Serbia | Terminated |
| Clinic.Neuro.Psych.Child.Youth Coordinator of this site? Confirm its status | Belgrade | Serbia | Terminated |
| Clinic for psychiatry, KCV Coordinator of this site? Confirm its status | Novi Sad | Serbia | Recruiting |
| State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital" Coordinator of this site? Confirm its status | Arkhangelsk | Russia | Terminated |
| Kazan State Medical University KSMU Coordinator of this site? Confirm its status | Kazan' | Russia | Suspended |
| SBHI Specialized Clinical Psychiatric Hospital 1 Coordinator of this site? Confirm its status | Krasnodar | Russia | Terminated |
| Regional Public Institution "Lipetsk Regional Psychoneurological Hospital" Coordinator of this site? Confirm its status | Lipetsk | Russia | Terminated |
| Joint-Stock Company Scientific Centre of Personalized Medicine Coordinator of this site? Confirm its status | Moscow | Russia | Terminated |
| SBHI of Moscow Region "Central Clinical Psychiatric Hospital" Coordinator of this site? Confirm its status | Moscow | Russia | Terminated |
| Clinical Psychiatry Hospital #1 of Nizhniy Novgorod Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Terminated |
| State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary Coordinator of this site? Confirm its status | Roshchino | Russia | Terminated |
| Center for Medical Rehabilitation named after S.S. Mnukhin Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Terminated |
| City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova Coordinator of this site? Confirm its status | Saint Petersburg | 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 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Terminated |
| Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Terminated |
| GBUZ Samara Regional Clinical Psychiatric Hospital Coordinator of this site? Confirm its status | Samara | Russia | Suspended |
| State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky" Coordinator of this site? Confirm its status | Saratov | Russia | Terminated |
| Smolensk State Medical University Coordinator of this site? Confirm its status | Smolensk | Russia | Suspended |
| LLC Podderzhka Coordinator of this site? Confirm its status | Stavropol | Russia | Terminated |
| LLC Clinic "Sto Let" Coordinator of this site? Confirm its status | Tomsk | Russia | Terminated |
| Stavropol Regional Psychiatric hospital #2 Coordinator of this site? Confirm its status | Tonnel'nyy | Russia | Terminated |
| Yaroslavl Regional Psychiatric Hospital Coordinator of this site? Confirm its status | Yaroslavl Region | Russia | Terminated |
| Regional Psychonevrological Hospital #3 Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Terminated |
| State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Terminated |
| SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine" Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Terminated |
| Kherson Regional Institution of Mental Care Coordinator of this site? Confirm its status | Kherson | Ukraine | Terminated |
| SI Research Institute of Psychiatry of MoH of Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Terminated |
| Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital Coordinator of this site? Confirm its status | Lviv | Ukraine | Terminated |
| Odesa Regional Medical Centre of Mental Health Coordinator of this site? Confirm its status | Odesa | Ukraine | Terminated |
| Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko" Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Terminated |
| Atlanta Behavioral Research, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Withdrawn |
| Atlanta Center for Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Completed |
| Bloomfield Hills MI Coordinator of this site? Confirm its status | Bloomfield Hills | United States | Withdrawn |
| UB Department of Psychiatry Coordinator of this site? Confirm its status | Buffalo | United States | Withdrawn |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Completed |
| ProScience Research Group Coordinator of this site? Confirm its status | Culver City | United States | Completed |
| Precise Research Centers Coordinator of this site? Confirm its status | Flowood | United States | Withdrawn |
| Manhattan Behavioral Medicine PLLC Coordinator of this site? Confirm its status | New York | United States | Withdrawn |
| Family Psychiatry of The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.