Schizophrenia Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 330 |
| Est. completion date | April 1, 2025 |
| Est. primary completion date | April 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years to 17 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Clinic of Child Psychiatry St. Nikolas | Sofia | |
| Bulgaria | MHAT Targovishte | Targovishte | |
| Colombia | 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 | |
| Mexico | 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 | Medical Care and Research S.A. de C.V. | Mérida | |
| Mexico | CIT Neuropsique | Monterrey | |
| Mexico | Iecsi S.C. | Monterrey | |
| Mexico | Instituto de Informacion e Investigacion en Salud Mental AC | Monterrey | |
| Mexico | BLIND Investigaciones SC | San Luis Potosí | |
| Romania | Socola Psychiatric Institute Iasi | Iasi | |
| Romania | Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti | Timisoara | |
| Russian Federation | 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 | 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 | City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova | 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 | Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko | 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 | |
| Serbia | Clinic.Neuro.Psych.Child.Youth | Belgrad | |
| Serbia | Institute for Mental Health | Belgrad | |
| Serbia | Clinic for psychiatry, KCV | Novi Sad | |
| Ukraine | 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 | Odesa Regional Medical Centre of Mental Health | Odesa | |
| Ukraine | Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko" | Vinnytsia | |
| United States | Atlanta Behavioral Research, LLC | Atlanta | Georgia |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | Bloomfield Hills MI | Bloomfield Hills | Michigan |
| United States | UB Department of Psychiatry | Buffalo | New York |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | ProScience Research Group | Culver City | California |
| United States | Precise Research Centers | Flowood | Mississippi |
| United States | Manhattan Behavioral Medicine PLLC | New York | New York |
| United States | Family Psychiatry of The Woodlands | The Woodlands | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Gedeon Richter Plc. |
United States, Bulgaria, Colombia, Mexico, Romania, Russian Federation, Serbia, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in PANSS total score at 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 |
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