Clinical trial NCT03817502: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Gedeon Richter Plc.
Sponsor class: INDUSTRY
First posted: 2019-01-25
Enrollment: 330
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in PANSS total score at Week 6
timeFrame: Baseline to Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Behavioral Research, LLC
state: Georgia
city: Bloomfield Hills
country: United States
facility: Bloomfield Hills MI
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Buffalo
country: United States
facility: UB Department of Psychiatry
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
city: Sofia
country: Bulgaria
facility: Clinic of Child Psychiatry St. Nikolas
city: Targovishte
country: Bulgaria
facility: MHAT Targovishte
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia
city: Bogotá
country: Colombia
facility: Centro de Investigacion del Sitema Nervioso CISNE
city: Bogotá
country: Colombia
facility: Instituto Colombiano Sistema Nervioso Clinica Monserrat
city: Pereira
country: Colombia
facility: Psynapsis Salud Mental SA
city: Culiacán
country: Mexico
facility: Centro para la Medicina y de Asistencia Medica Especializada S.C.
city: Durango
country: Mexico
facility: Instituto de Investigacion Clinica AC
city: Guadalajara
country: Mexico
facility: Consultorio de Medicina Especializada del Sector Privado
city: Guanajuato
country: Mexico
facility: Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
city: Monterrey
country: Mexico
facility: Iecsi S.C.
city: Monterrey
country: Mexico
facility: CIT Neuropsique
city: Monterrey
country: Mexico
facility: Instituto de Informacion e Investigacion en Salud Mental AC
city: Mérida
country: Mexico
facility: Medical Care and Research S.A. de C.V.
city: San Luis Potosí
country: Mexico
facility: BLIND Investigaciones SC
city: Iaşi
country: Romania
facility: Socola Psychiatric Institute Iasi
city: Timişoara
country: Romania
facility: Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
city: Arkhangel'sk
country: Russian Federation
facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
city: Kazan
country: Russian Federation
facility: Kazan State Medical University KSMU
city: Krasnodar
country: Russian Federation
facility: SBHI Specialized Clinical Psychiatric Hospital 1
city: Lipetsk
country: Russian Federation
facility: Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
city: Moscow
country: Russian Federation
facility: Joint-Stock Company Scientific Centre of Personalized Medicine
city: Moscow
country: Russian Federation
facility: SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
city: Nizhny Novgorod
country: Russian Federation
facility: Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
city: Roshchino
country: Russian Federation
facility: State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
city: Saint Petersburg
country: Russian Federation
facility: 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
city: Saint Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
city: Saint-Petersburg
country: Russian Federation
facility: Center for Medical Rehabilitation named after S.S. Mnukhin
city: Samara
country: Russian Federation
facility: GBUZ Samara Regional Clinical Psychiatric Hospital
city: Saratov
country: Russian Federation
facility: State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Stavropol
country: Russian Federation
facility: LLC Podderzhka
city: Tomsk
country: Russian Federation
facility: LLC Clinic "Sto Let"
city: Tonnel'nyy
country: Russian Federation
facility: Stavropol Regional Psychiatric hospital #2
city: Yaroslavl Region
country: Russian Federation
facility: Yaroslavl Regional Psychiatric Hospital
city: Belgrad
country: Serbia
facility: Clinic.Neuro.Psych.Child.Youth
city: Belgrad
country: Serbia
facility: Institute for Mental Health
city: Novi Sad
country: Serbia
facility: Clinic for psychiatry, KCV
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Psychonevrological Hospital #3
city: Kharkiv
country: Ukraine
facility: SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
city: Kharkov
country: Ukraine
facility: State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
city: Kherson
country: Ukraine
facility: Kherson Regional Institution of Mental Care
city: Kyiv
country: Ukraine
facility: SI Research Institute of Psychiatry of MoH of Ukraine
city: Lviv
country: Ukraine
facility: Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
city: Odesa
country: Ukraine
facility: Odesa Regional Medical Centre of Mental Health
city: Vinnytsia
country: Ukraine
facility: Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"
Study officials:
References: