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
Who is this study for? Adolescents aged 13-17 with schizophrenia
What treatments are being studied? Cariprazine
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:
• 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).
Locations
United States
California
ProScience Research Group
COMPLETED
Culver City
Georgia
Atlanta Behavioral Research, LLC
WITHDRAWN
Atlanta
Atlanta Center for Medical Research
COMPLETED
Atlanta
Michigan
Bloomfield Hills MI
WITHDRAWN
Bloomfield Hills
Mississippi
Precise Research Centers
WITHDRAWN
Flowood
New York
UB Department of Psychiatry
WITHDRAWN
Buffalo
Manhattan Behavioral Medicine PLLC
WITHDRAWN
New York
Ohio
University of Cincinnati
COMPLETED
Cincinnati
Texas
Family Psychiatry of The Woodlands
COMPLETED
The Woodlands
Other Locations
Bulgaria
Clinic of Child Psychiatry St. Nikolas
RECRUITING
Sofia
MHAT Targovishte
RECRUITING
Targovishte
Colombia
Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
SUSPENDED
Barranquilla
E.S.E. Hospital Mental de Antioquia
SUSPENDED
Bello
Centro de Investigacion del Sitema Nervioso CISNE
SUSPENDED
Bogotá
Instituto Colombiano Sistema Nervioso Clinica Monserrat
SUSPENDED
Bogotá
Psynapsis Salud Mental SA
SUSPENDED
Pereira
Mexico
Centro para la Medicina y de Asistencia Medica Especializada S.C.
SUSPENDED
Culiacán
Instituto de Investigacion Clinica AC
SUSPENDED
Durango
Consultorio de Medicina Especializada del Sector Privado
WITHDRAWN
Guadalajara
Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
SUSPENDED
Guanajuato City
Medical Care and Research S.A. de C.V.
ACTIVE_NOT_RECRUITING
Mérida
CIT Neuropsique
SUSPENDED
Monterrey
Iecsi S.C.
SUSPENDED
Monterrey
Instituto de Informacion e Investigacion en Salud Mental AC
SUSPENDED
Monterrey
BLIND Investigaciones SC
SUSPENDED
San Luis Potosí City
Romania
Socola Psychiatric Institute Iasi
WITHDRAWN
Iași
Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
RECRUITING
Timișoara
Russian Federation
State Institution of Healthcare Arkhangelsk Regional Clinical Psychiatric Hospital
TERMINATED
Arkhangelsk
Kazan State Medical University KSMU
SUSPENDED
Kazan'
SBHI Specialized Clinical Psychiatric Hospital 1
TERMINATED
Krasnodar
Regional Public Institution Lipetsk Regional Psychoneurological Hospital
TERMINATED
Lipetsk
Joint-Stock Company Scientific Centre of Personalized Medicine
TERMINATED
Moscow
SBHI of Moscow Region Central Clinical Psychiatric Hospital
TERMINATED
Moscow
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
TERMINATED
Nizhny Novgorod
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
TERMINATED
Roshchino
Center for Medical Rehabilitation named after S.S. Mnukhin
TERMINATED
Saint Petersburg
City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
TERMINATED
Saint Petersburg
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
TERMINATED
Saint Petersburg
Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
TERMINATED
Saint Petersburg
GBUZ Samara Regional Clinical Psychiatric Hospital
SUSPENDED
Samara
State Budgetary Healthcare Institution Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky
TERMINATED
Saratov
Smolensk State Medical University
SUSPENDED
Smolensk
LLC Podderzhka
TERMINATED
Stavropol
LLC Clinic Sto Let
TERMINATED
Tomsk
Stavropol Regional Psychiatric hospital #2
TERMINATED
Tonnel’nyy
Yaroslavl Regional Psychiatric Hospital
TERMINATED
Yaroslavl Region
Serbia
Clinic.Neuro.Psych.Child.Youth
TERMINATED
Belgrade
Institute for Mental Health
TERMINATED
Belgrade
Clinic for psychiatry, KCV
RECRUITING
Novi Sad
Ukraine
Regional Psychonevrological Hospital #3
TERMINATED
Ivano-frankivsk
SI Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine
TERMINATED
Kharkiv
State Institution Institute of Health Care for Children and Adolescents of the AMS of Ukraine
TERMINATED
Kharkiv
Kherson Regional Institution of Mental Care
TERMINATED
Kherson
SI Research Institute of Psychiatry of MoH of Ukraine
TERMINATED
Kyiv
Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
TERMINATED
Lviv
Odesa Regional Medical Centre of Mental Health
TERMINATED
Odesa
Municipal Institution Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko
TERMINATED
Vinnytsia
Contact Information
Primary
Balázs Lázár
RA.ctaRichter@richter.hu
+36 1 432 6437
Time Frame
Start Date: 2019-06-06
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 330
Treatments
Experimental: Cariprazine 1.5 mg/d
Cariprazine capsules, oral administration, once daily.
Experimental: Cariprazine 4.5 mg/d
Cariprazine capsules, oral administration, once daily.
Placebo_comparator: Placebo
Matching placebo capsules, oral administration, once daily.
Related Therapeutic Areas
Sponsors
Leads: Gedeon Richter Plc.