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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Cariprazine
  Cariprazine capsules, oral administration, once daily.
• Препарат Placebo
  Matching placebo capsules, oral administration, once daily.

Первичные конечные точки

• Change from baseline in PANSS total score at Week 6 [Срок оценки: Baseline to Week 6]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Россия · 19 центров

• State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital" — Arkhangelsk
• Kazan State Medical University KSMU — Kazan'
• SBHI Specialized Clinical Psychiatric Hospital 1 — Krasnodar
• Regional Public Institution "Lipetsk Regional Psychoneurological Hospital" — Lipetsk
• Joint-Stock Company Scientific Centre of Personalized Medicine — Moscow
• SBHI of Moscow Region "Central Clinical Psychiatric Hospital" — Moscow
• Clinical Psychiatry Hospital #1 of Nizhniy Novgorod — Nizhny Novgorod
• State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary — Roshchino
• … и ещё 11 центров

США · 9 центров

• ProScience Research Group — Culver City
• Atlanta Center for Medical Research — Atlanta
• Atlanta Behavioral Research, LLC — Atlanta
• Bloomfield Hills MI — Bloomfield Hills
• Precise Research Centers — Flowood
• UB Department of Psychiatry — Buffalo
• Manhattan Behavioral Medicine PLLC — New York
• University of Cincinnati — Cincinnati
• … и ещё 1 центр

Мексика · 9 центров

• Centro para la Medicina y de Asistencia Medica Especializada S.C. — Culiacán
• Instituto de Investigacion Clinica AC — Durango
• Consultorio de Medicina Especializada del Sector Privado — Guadalajara
• Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra — Guanajuato City
• Medical Care and Research S.A. de C.V. — Mérida
• Iecsi S.C. — Monterrey
• CIT Neuropsique — Monterrey
• Instituto de Informacion e Investigacion en Salud Mental AC — Monterrey
• … и ещё 1 центр

Украина · 8 центров

• Regional Psychonevrological Hospital #3 — Ivano-Frankivsk
• SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine" — Kharkiv
• State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukr — Kharkiv
• Kherson Regional Institution of Mental Care — Kherson
• SI Research Institute of Psychiatry of MoH of Ukraine — Kyiv
• Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital — Lviv
• Odesa Regional Medical Centre of Mental Health — Odesa
• Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yush — Vinnytsia

Колумбия · 5 центров

• Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS. — Barranquilla
• E.S.E. Hospital Mental de Antioquia — Bello
• Centro de Investigacion del Sitema Nervioso CISNE — Bogotá
• Instituto Colombiano Sistema Nervioso Clinica Monserrat — Bogotá
• Psynapsis Salud Mental SA — Pereira

Сербия · 3 центра

• Clinic.Neuro.Psych.Child.Youth — Belgrade
• Institute for Mental Health — Belgrade
• Clinic for psychiatry, KCV — Novi Sad

Болгария · 2 центра

• Clinic of Child Psychiatry St. Nikolas — Sofia
• MHAT Targovishte — Targovishte

Румыния · 2 центра

• Socola Psychiatric Institute Iasi — Iași
• Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adole — Timișoara

Идентификаторы

NCT: NCT03817502 · RGH-MD-20 · 2018-004006-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗