Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
October 7, 2025 updated by: Gedeon Richter Plc.
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
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
330
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Balázs Lázár
- Phone Number: +36 1 432 6437
- Email: RA.ctaRichter@richter.hu
Study Locations
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Sofia, Bulgaria, 1431
- Recruiting
- Clinic of Child Psychiatry St. Nikolas
-
Targovishte, Bulgaria, 7700
- Recruiting
- MHAT Targovishte
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Barranquilla, Colombia, 080020
- Suspended
- Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
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Bello, Colombia, 051053
- Suspended
- E.S.E. Hospital Mental de Antioquia
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Bogotá, Colombia, 1111666
- Suspended
- Centro de Investigacion del Sitema Nervioso CISNE
-
Bogotá, Colombia, 250051
- Suspended
- Instituto Colombiano Sistema Nervioso Clinica Monserrat
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Pereira, Colombia, 660003
- Suspended
- Psynapsis Salud Mental SA
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-
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Culiacán, Mexico, 80230
- Suspended
- Centro para la Medicina y de Asistencia Medica Especializada S.C.
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Durango, Mexico, 34000
- Suspended
- Instituto de Investigacion Clinica AC
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Guadalajara, Mexico, 44690
- Withdrawn
- Consultorio de Medicina Especializada del Sector Privado
-
Guanajuato City, Mexico, 37000
- Suspended
- Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
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Monterrey, Mexico, 64310
- Suspended
- Iecsi S.C.
-
Monterrey, Mexico, 64610
- Suspended
- cit NEUROPSIQUE
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Monterrey, Mexico, 64710
- Suspended
- Instituto de Informacion e Investigacion en Salud Mental AC
-
Mérida, Mexico, 97070
- Active, not recruiting
- Medical Care and Research S.A. de C.V.
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San Luis Potosí City, Mexico, 78213
- Suspended
- BLIND Investigaciones SC
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-
-
-
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Iași, Romania, 700282
- Withdrawn
- Socola Psychiatric Institute Iasi
-
Timișoara, Romania, 300230
- Recruiting
- Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
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-
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-
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Arkhangelsk, Russia, 163530
- Terminated
- State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
-
Kazan', Russia, 420012
- Suspended
- Kazan State Medical University KSMU
-
Krasnodar, Russia, 350007
- Terminated
- SBHI Specialized Clinical Psychiatric Hospital 1
-
Lipetsk, Russia, 399083
- Terminated
- Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
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Moscow, Russia, 105082
- Terminated
- Joint-Stock Company Scientific Centre of Personalized Medicine
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Moscow, Russia, 127083
- Terminated
- SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
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Nizhny Novgorod, Russia, 603155
- Terminated
- Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
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Roshchino, Russia, 188820
- Terminated
- State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
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Saint Petersburg, Russia, 190121
- Terminated
- Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
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Saint Petersburg, Russia, 192019
- 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
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Saint Petersburg, Russia, 197022
- Terminated
- Center for Medical Rehabilitation named after S.S. Mnukhin
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Saint Petersburg, Russia, 197341
- Terminated
- City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
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Samara, Russia, 443016
- Suspended
- GBUZ Samara Regional Clinical Psychiatric Hospital
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Saratov, Russia, 410028
- Terminated
- State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
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Smolensk, Russia, 214019
- Suspended
- Smolensk State Medical University
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Stavropol, Russia, 355038
- Terminated
- LLC Podderzhka
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Tomsk, Russia, 634014
- Terminated
- LLC Clinic "Sto Let"
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Tonnel'nyy, Russia, 357034
- Terminated
- Stavropol Regional Psychiatric hospital #2
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Yaroslavl Region, Russia, 634009
- Terminated
- Yaroslavl Regional Psychiatric Hospital
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Belgrade, Serbia, 11000
- Terminated
- Clinic.Neuro.Psych.Child.Youth
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Belgrade, Serbia, 11000
- Terminated
- Institute for Mental Health
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Novi Sad, Serbia, 21000
- Recruiting
- Clinic for psychiatry, KCV
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-
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Ivano-Frankivsk, Ukraine, 76011
- Terminated
- Regional Psychonevrological Hospital #3
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Kharkiv, Ukraine, 61068
- Terminated
- SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
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Kharkiv, Ukraine, 61153
- Terminated
- State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
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Kherson, Ukraine, 73488
- Terminated
- Kherson Regional Institution of Mental Care
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Kyiv, Ukraine, 04108
- Terminated
- SI Research Institute of Psychiatry of MoH of Ukraine
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Lviv, Ukraine, 79021
- Terminated
- Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
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Odesa, Ukraine, 65006
- Terminated
- Odesa Regional Medical Centre of Mental Health
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Vinnytsia, Ukraine, 21018
- Terminated
- Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"
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California
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Culver City, California, United States, 90230
- Completed
- Proscience Research Group
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Georgia
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Atlanta, Georgia, United States, 30331
- Completed
- Atlanta Center for Medical Research
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Atlanta, Georgia, United States, 30338
- Withdrawn
- Atlanta Behavioral Research, LLC
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Michigan
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Bloomfield Hills, Michigan, United States, 48302
- Withdrawn
- Bloomfield Hills MI
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Mississippi
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Flowood, Mississippi, United States, 39232
- Withdrawn
- Precise Research Centers
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New York
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Buffalo, New York, United States, 142515
- Withdrawn
- UB Department of Psychiatry
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New York, New York, United States, 10036
- Withdrawn
- Manhattan Behavioral Medicine PLLC
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Ohio
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Cincinnati, Ohio, United States, 45219
- Completed
- University of Cincinnati
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Texas
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The Woodlands, Texas, United States, 77381
- Completed
- Family Psychiatry of The Woodlands
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cariprazine 1.5 mg/d
Cariprazine capsules, oral administration, once daily.
|
Cariprazine capsules, oral administration, once daily.
|
|
Experimental: Cariprazine 4.5 mg/d
Cariprazine capsules, oral administration, once daily.
|
Cariprazine capsules, oral administration, once daily.
|
|
Placebo Comparator: Placebo
Matching placebo capsules, oral administration, once daily.
|
Matching placebo capsules, oral administration, once daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in PANSS total score at Week 6
Time Frame: Baseline to Week 6
|
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia.
The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants.
This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology.
Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact.
The cumulative score ranges from 30 to 210.
A negative change from baseline score indicates improvement.
|
Baseline to Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2019
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
December 15, 2026
Study Registration Dates
First Submitted
January 24, 2019
First Submitted That Met QC Criteria
January 24, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Estimated)
October 8, 2025
Last Update Submitted That Met QC Criteria
October 7, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RGH-MD-20
- 2018-004006-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
For more information please contact ra.ctarichter@richter.hu.
IPD Sharing Time Frame
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
IPD Sharing Access Criteria
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.