Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Recruiting · NCT03817502 · Interventional (participants receive a specific treatment) · Lead sponsor: Gedeon Richter Plc.
View the official record on ClinicalTrials.gov →Interventions studied
CariprazinePlacebo
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Who can take part
Age range
13 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
57 locations listed across 7 US states.
- 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
- State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital" - Arkhangelsk, Russia
- Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS. - Barranquilla, Colombia
- Clinic.Neuro.Psych.Child.Youth - Belgrade, Serbia
- Institute for Mental Health - Belgrade, Serbia
- 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
- 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
- Socola Psychiatric Institute Iasi - Iași, Romania
- Regional Psychonevrological Hospital #3 - Ivano-Frankivsk, Ukraine
- Kazan State Medical University KSMU - Kazan', Russia
- 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
- SBHI Specialized Clinical Psychiatric Hospital 1 - Krasnodar, Russia
- SI Research Institute of Psychiatry of MoH of Ukraine - Kyiv, Ukraine
- Regional Public Institution "Lipetsk Regional Psychoneurological Hospital" - Lipetsk, Russia
- Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital - Lviv, Ukraine
- Iecsi S.C. - Monterrey, Mexico
- CIT Neuropsique - Monterrey, Mexico
- Instituto de Informacion e Investigacion en Salud Mental AC - Monterrey, Mexico
- Joint-Stock Company Scientific Centre of Personalized Medicine - Moscow, Russia
- SBHI of Moscow Region "Central Clinical Psychiatric Hospital" - Moscow, Russia
- Medical Care and Research S.A. de C.V. - Mérida, Mexico
- Clinical Psychiatry Hospital #1 of Nizhniy Novgorod - Nizhny Novgorod, Russia
- Clinic for psychiatry, KCV - Novi Sad, Serbia
- Odesa Regional Medical Centre of Mental Health - Odesa, Ukraine
- Psynapsis Salud Mental SA - Pereira, Colombia
- 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
- BLIND Investigaciones SC - San Luis Potosí City, Mexico
- State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky" - Saratov, Russia
- Smolensk State Medical University - Smolensk, Russia
- Clinic of Child Psychiatry St. Nikolas - Sofia, Bulgaria
- LLC Podderzhka - Stavropol, Russia
- MHAT Targovishte - Targovishte, Bulgaria
- Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti - Timișoara, Romania
- LLC Clinic "Sto Let" - Tomsk, Russia
- Stavropol Regional Psychiatric hospital #2 - Tonnel’nyy, Russia
- Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko" - Vinnytsia, Ukraine
- Yaroslavl Regional Psychiatric Hospital - Yaroslavl Region, Russia