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

December 15, 2022 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Clinic of Child Psychiatry St. Nikolas
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • MHAT Targovishte
  • Colombia
      • Barranquilla, Colombia, 080020
        • Recruiting
        • Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
      • Bello, Colombia, 051053
        • Recruiting
        • E.S.E. Hospital Mental de Antioquia
      • Bogotá, Colombia, 1111666
        • Recruiting
        • Centro de Investigacion del Sitema Nervioso CISNE
      • Bogotá, Colombia, 250051
        • Recruiting
        • Instituto Colombiano Sistema Nervioso Clinica Monserrat
      • Pereira, Colombia, 660003
        • Recruiting
        • Psynapsis Salud Mental SA
  • Mexico
      • Culiacán, Mexico, 80230
        • Recruiting
        • Centro para la Medicina y de Asistencia Medica Especializada S.C.
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigacion Clinica AC
      • Guadalajara, Mexico, 44690
        • Not yet recruiting
        • Consultorio de Medicina Especializada del Sector Privado
      • Guanajuato, Mexico, 37000
        • Recruiting
        • Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
      • Monterrey, Mexico, 64310
        • Recruiting
        • Iecsi S.C.
      • Monterrey, Mexico, 64610
        • Recruiting
        • cit NEUROPSIQUE
      • Monterrey, Mexico, 64710
        • Recruiting
        • Instituto de informacion e investigacion en salud mental AC
      • Mérida, Mexico, 97070
        • Recruiting
        • Medical Care and Research S.A. de C.V.
      • San Luis Potosí, Mexico, 78213
        • Recruiting
        • BLIND Investigaciones SC
  • Romania
      • Iaşi, Romania, 700282
        • Withdrawn
        • Socola Psychiatric Institute Iasi
      • Timişoara, Romania, 300230
        • Recruiting
        • Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
  • Russian Federation
      • Arkhangel'sk, Russian Federation, 163530
        • Withdrawn
        • State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
      • Kazan, Russian Federation, 420012
        • Suspended
        • Kazan State Medical University KSMU
      • Krasnodar, Russian Federation, 350007
        • Withdrawn
        • SBHI Specialized Clinical Psychiatric Hospital 1
      • Lipetsk, Russian Federation, 399083
        • Suspended
        • Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
      • Moscow, Russian Federation, 105082
        • Suspended
        • Joint-Stock Company Scientific Centre of Personalized Medicine
      • Moscow, Russian Federation, 127083
        • Suspended
        • SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
      • Nizhny Novgorod, Russian Federation, 603155
        • Suspended
        • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
      • Roshchino, Russian Federation, 188820
        • Suspended
        • State PUblic Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
      • Saint Petersburg, Russian Federation, 190121
        • Suspended
        • Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
      • Saint Petersburg, Russian Federation, 192019
        • Suspended
        • 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, Russian Federation, 197341
        • Suspended
        • City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
      • Saint-Petersburg, Russian Federation, 197022
        • Withdrawn
        • Center for Medical Rehabilitation named after S.S. Mnukhin
      • Samara, Russian Federation, 443016
        • Suspended
        • GBUZ Samara Regional Clinical Psychiatric Hospital
      • Saratov, Russian Federation, 410028
        • Suspended
        • State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
      • Smolensk, Russian Federation, 214019
        • Suspended
        • Smolensk State Medical University
      • Stavropol, Russian Federation, 355038
        • Suspended
        • LLC Podderzhka
      • Tomsk, Russian Federation, 634014
        • Suspended
        • LLC Clinic "Sto Let"
      • Tonnel'nyy, Russian Federation, 357034
        • Withdrawn
        • Stavropol Regional Psychiatric hospital #2
      • Yaroslavl Region, Russian Federation, 634009
        • Completed
        • Yaroslavl Regional Psychiatric Hospital
  • Serbia
      • Belgrad, Serbia, 11000
        • Recruiting
        • Clinic.Neuro.Psych.Child.Youth
      • Belgrad, Serbia, 11000
        • Recruiting
        • Institute for Mental Health
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinic for psychiatry, KCV
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76011
        • Completed
        • Regional Psychonevrological Hospital #3
      • Kharkiv, Ukraine, 61068
        • Completed
        • SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
      • Kharkov, Ukraine, 61153
        • Withdrawn
        • State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
      • Kherson, Ukraine, 73488
        • Withdrawn
        • Kherson Regional Institution of Mental Care
      • Kyiv, Ukraine, 04108
        • Withdrawn
        • SI Research Institute of Psychiatry of MoH of Ukraine
      • Lviv, Ukraine, 79021
        • Withdrawn
        • 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
        • Withdrawn
        • 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

Ages Eligible for Study

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

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)

June 6, 2019

Primary Completion (ANTICIPATED)

April 1, 2025

Study Completion (ANTICIPATED)

April 1, 2025

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 (ACTUAL)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

February 1, 2022

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.

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