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

Phase 3

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Cariprazine

• Registration Number: NCT03817502
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Study Start: 2019-06-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo capsules, oral administration, once daily.
Cariprazine 1.5 mg/d	Cariprazine	Cariprazine capsules, oral administration, once daily.
Cariprazine 4.5 mg/d	Cariprazine	Cariprazine capsules, oral administration, once daily.

Primary Outcome Measures

Name	Time	Method
Change from baseline in PANSS total score at Week 6	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.

Trial Locations

Locations (57)

SBHI of Moscow Region "Central Clinical Psychiatric Hospital"; 🇷🇺 Moscow, Russian Federation

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod; 🇷🇺 Nizhny Novgorod, Russian Federation

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary; 🇷🇺 Roshchino, Russian Federation

Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko; 🇷🇺 Saint Petersburg, Russian Federation

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

City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova; 🇷🇺 Saint Petersburg, Russian Federation

Center for Medical Rehabilitation named after S.S. Mnukhin; 🇷🇺 Saint-Petersburg, Russian Federation

GBUZ Samara Regional Clinical Psychiatric Hospital; 🇷🇺 Samara, Russian Federation

State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"; 🇷🇺 Saratov, Russian Federation

Smolensk State Medical University; 🇷🇺 Smolensk, Russian Federation

LLC Podderzhka; 🇷🇺 Stavropol, Russian Federation

LLC Clinic "Sto Let"; 🇷🇺 Tomsk, Russian Federation

Stavropol Regional Psychiatric hospital #2; 🇷🇺 Tonnel'nyy, Russian Federation

Yaroslavl Regional Psychiatric Hospital; 🇷🇺 Yaroslavl Region, Russian Federation

Clinic.Neuro.Psych.Child.Youth; 🇷🇸 Belgrad, Serbia

Institute for Mental Health; 🇷🇸 Belgrad, 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; 🇺🇦 Kharkov, 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

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, Mexico

Iecsi S.C.; 🇲🇽 Monterrey, Mexico

CIT Neuropsique; 🇲🇽 Monterrey, Mexico

Instituto de Informacion e Investigacion en Salud Mental AC; 🇲🇽 Monterrey, Mexico

Medical Care and Research S.A. de C.V.; 🇲🇽 Mérida, Mexico

BLIND Investigaciones SC; 🇲🇽 San Luis Potosí, Mexico

Socola Psychiatric Institute Iasi; 🇷🇴 Iaşi, Romania

Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti; 🇷🇴 Timişoara, Romania

State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"; 🇷🇺 Arkhangel'sk, Russian Federation

Kazan State Medical University KSMU; 🇷🇺 Kazan, Russian Federation

SBHI Specialized Clinical Psychiatric Hospital 1; 🇷🇺 Krasnodar, Russian Federation

Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"; 🇷🇺 Lipetsk, Russian Federation

Joint-Stock Company Scientific Centre of Personalized Medicine; 🇷🇺 Moscow, Russian Federation

Odesa Regional Medical Centre of Mental Health; 🇺🇦 Odesa, Ukraine

Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"; 🇺🇦 Vinnytsia, Ukraine