Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
NCT ID: NCT03817502
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
330 participants
INTERVENTIONAL
2019-06-06
2026-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cariprazine 1.5 mg/d
Cariprazine capsules, oral administration, once daily.
Cariprazine
Cariprazine capsules, oral administration, once daily.
Cariprazine 4.5 mg/d
Cariprazine capsules, oral administration, once daily.
Cariprazine
Cariprazine capsules, oral administration, once daily.
Placebo
Matching placebo capsules, oral administration, once daily.
Placebo
Matching placebo capsules, oral administration, once daily.
Interventions
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Cariprazine
Cariprazine capsules, oral administration, once daily.
Placebo
Matching placebo capsules, oral administration, once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
17 Years
ALL
No
Sponsors
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Gedeon Richter Plc.
INDUSTRY
Responsible Party
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Locations
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ProScience Research Group
Culver City, California, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia, United States
Bloomfield Hills MI
Bloomfield Hills, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
UB Department of Psychiatry
Buffalo, New York, United States
Manhattan Behavioral Medicine PLLC
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, United States
Clinic of Child Psychiatry St. Nikolas
Sofia, , Bulgaria
MHAT Targovishte
Targovishte, , Bulgaria
Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
Barranquilla, , Colombia
E.S.E. Hospital Mental de Antioquia
Bello, , Colombia
Centro de Investigacion del Sitema Nervioso CISNE
Bogotá, , Colombia
Instituto Colombiano Sistema Nervioso Clinica Monserrat
Bogotá, , Colombia
Psynapsis Salud Mental SA
Pereira, , Colombia
Centro para la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, , Mexico
Instituto de Investigacion Clinica AC
Durango, , Mexico
Consultorio de Medicina Especializada del Sector Privado
Guadalajara, , Mexico
Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
Guanajuato City, , Mexico
Medical Care and Research S.A. de C.V.
Mérida, , Mexico
Iecsi S.C.
Monterrey, , Mexico
CIT Neuropsique
Monterrey, , Mexico
Instituto de Informacion e Investigacion en Salud Mental AC
Monterrey, , Mexico
BLIND Investigaciones SC
San Luis Potosí City, , Mexico
Socola Psychiatric Institute Iasi
Iași, , Romania
Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
Timișoara, , Romania
State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
Arkhangelsk, , Russia
Kazan State Medical University KSMU
Kazan', , Russia
SBHI Specialized Clinical Psychiatric Hospital 1
Krasnodar, , Russia
Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
Lipetsk, , Russia
Joint-Stock Company Scientific Centre of Personalized Medicine
Moscow, , Russia
SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
Moscow, , Russia
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
Nizhny Novgorod, , Russia
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
Roshchino, , Russia
Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
Saint Petersburg, , Russia
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
Center for Medical Rehabilitation named after S.S. Mnukhin
Saint Petersburg, , Russia
City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
Saint Petersburg, , Russia
GBUZ Samara Regional Clinical Psychiatric Hospital
Samara, , Russia
State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
Saratov, , Russia
Smolensk State Medical University
Smolensk, , Russia
LLC Podderzhka
Stavropol, , Russia
LLC Clinic "Sto Let"
Tomsk, , Russia
Stavropol Regional Psychiatric hospital #2
Tonnel'nyy, , Russia
Yaroslavl Regional Psychiatric Hospital
Yaroslavl Region, , Russia
Clinic.Neuro.Psych.Child.Youth
Belgrade, , Serbia
Institute for Mental Health
Belgrade, , Serbia
Clinic for psychiatry, KCV
Novi Sad, , Serbia
Regional Psychonevrological Hospital #3
Ivano-Frankivsk, , Ukraine
SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
Kharkiv, , Ukraine
State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
Kharkiv, , Ukraine
Kherson Regional Institution of Mental Care
Kherson, , Ukraine
SI Research Institute of Psychiatry of MoH of Ukraine
Kyiv, , Ukraine
Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
Lviv, , Ukraine
Odesa Regional Medical Centre of Mental Health
Odesa, , Ukraine
Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"
Vinnytsia, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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RGH-MD-20
Identifier Type: -
Identifier Source: org_study_id
2018-004006-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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