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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Clinic of Child Psychiatry St. Nikolas
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • MHAT Targovishte
  • Colombia
      • Barranquilla, Colombia, 080020
        • Suspended
        • Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
      • Bello, Colombia, 051053
        • Suspended
        • E.S.E. Hospital Mental de Antioquia
      • Bogotá, Colombia, 1111666
        • Suspended
        • Centro de Investigacion del Sitema Nervioso CISNE
      • Bogotá, Colombia, 250051
        • Suspended
        • Instituto Colombiano Sistema Nervioso Clinica Monserrat
      • Pereira, Colombia, 660003
        • Suspended
        • Psynapsis Salud Mental SA
  • Mexico
      • Culiacán, Mexico, 80230
        • Suspended
        • Centro para la Medicina y de Asistencia Medica Especializada S.C.
      • Durango, Mexico, 34000
        • Suspended
        • Instituto de Investigacion Clinica AC
      • 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
      • Monterrey, Mexico, 64310
        • Suspended
        • Iecsi S.C.
      • Monterrey, Mexico, 64610
        • Suspended
        • cit NEUROPSIQUE
      • 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.
      • San Luis Potosí City, Mexico, 78213
        • Suspended
        • BLIND Investigaciones SC
  • Romania
      • 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
  • Russia
      • 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"
      • Moscow, Russia, 105082
        • Terminated
        • Joint-Stock Company Scientific Centre of Personalized Medicine
      • Moscow, Russia, 127083
        • Terminated
        • SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
      • Nizhny Novgorod, Russia, 603155
        • Terminated
        • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
      • Roshchino, Russia, 188820
        • Terminated
        • State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
      • Saint Petersburg, Russia, 190121
        • Terminated
        • Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
      • 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
      • Saint Petersburg, Russia, 197022
        • Terminated
        • Center for Medical Rehabilitation named after S.S. Mnukhin
      • Saint Petersburg, Russia, 197341
        • Terminated
        • City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
      • Samara, Russia, 443016
        • Suspended
        • GBUZ Samara Regional Clinical Psychiatric Hospital
      • Saratov, Russia, 410028
        • Terminated
        • State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
      • Smolensk, Russia, 214019
        • Suspended
        • Smolensk State Medical University
      • Stavropol, Russia, 355038
        • Terminated
        • LLC Podderzhka
      • Tomsk, Russia, 634014
        • Terminated
        • LLC Clinic "Sto Let"
      • Tonnel'nyy, Russia, 357034
        • Terminated
        • Stavropol Regional Psychiatric hospital #2
      • Yaroslavl Region, Russia, 634009
        • Terminated
        • Yaroslavl Regional Psychiatric Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Terminated
        • Clinic.Neuro.Psych.Child.Youth
      • Belgrade, Serbia, 11000
        • Terminated
        • Institute for Mental Health
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinic for psychiatry, KCV
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76011
        • Terminated
        • Regional Psychonevrological Hospital #3
      • Kharkiv, Ukraine, 61068
        • Terminated
        • SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
      • Kharkiv, Ukraine, 61153
        • Terminated
        • State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
      • Kherson, Ukraine, 73488
        • Terminated
        • Kherson Regional Institution of Mental Care
      • Kyiv, Ukraine, 04108
        • Terminated
        • SI Research Institute of Psychiatry of MoH of Ukraine
      • Lviv, Ukraine, 79021
        • Terminated
        • Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
      • Odesa, Ukraine, 65006
        • Terminated
        • Odesa Regional Medical Centre of Mental Health
      • Vinnytsia, Ukraine, 21018
        • Terminated
        • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"
  • United States
    • California
      • Culver City, California, United States, 90230
        • Completed
        • Proscience Research Group
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Completed
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30338
        • Withdrawn
        • Atlanta Behavioral Research, LLC
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Withdrawn
        • Bloomfield Hills MI
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Withdrawn
        • Precise Research Centers
    • New York
      • Buffalo, New York, United States, 142515
        • Withdrawn
        • UB Department of Psychiatry
      • New York, New York, United States, 10036
        • Withdrawn
        • Manhattan Behavioral Medicine PLLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Completed
        • University of Cincinnati
    • Texas
      • The Woodlands, Texas, United States, 77381
        • Completed
        • Family Psychiatry of The Woodlands

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cariprazine 1.5 mg/d
Cariprazine capsules, oral administration, once daily.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.
Experimental: Cariprazine 4.5 mg/d
Cariprazine capsules, oral administration, once daily.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.
Placebo Comparator: Placebo
Matching placebo capsules, oral administration, once daily.
Drug: Placebo
Matching placebo capsules, oral administration, once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gedeon Richter Plc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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