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

Sponsor

Gedeon Richter Plc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03817502

Collaborator

(none)

330

Enrollment

Locations

Arms

69.8

Anticipated Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Cariprazine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 6, 2019

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cariprazine 1.5 mg/d Cariprazine capsules, oral administration, once daily.	Drug: Cariprazine Cariprazine capsules, oral administration, once daily.
Experimental: Cariprazine 4.5 mg/d Cariprazine capsules, oral administration, once daily.	Drug: Cariprazine Cariprazine capsules, oral administration, once daily.
Placebo Comparator: Placebo Matching placebo capsules, oral administration, once daily.	Drug: Placebo Matching placebo capsules, oral administration, once daily.

Arm

Intervention/Treatment

Experimental: Cariprazine 1.5 mg/d

Cariprazine capsules, oral administration, once daily.

Drug: Cariprazine

Cariprazine capsules, oral administration, once daily.

Experimental: Cariprazine 4.5 mg/d

Cariprazine capsules, oral administration, once daily.

Drug: Cariprazine

Cariprazine capsules, oral administration, once daily.

Placebo Comparator: Placebo

Matching placebo capsules, oral administration, once daily.

Drug: Placebo

Matching placebo capsules, oral administration, once daily.

Outcome Measures

Primary Outcome Measures

Change from baseline in PANSS total score at Week 6 [Baseline to 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProScience Research Group	Culver City	California	United States	90230
2	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
3	Atlanta Behavioral Research, LLC	Atlanta	Georgia	United States	30338
4	Bloomfield Hills MI	Bloomfield Hills	Michigan	United States	48302
5	Precise Research Centers	Flowood	Mississippi	United States	39232
6	UB Department of Psychiatry	Buffalo	New York	United States	142515
7	Manhattan Behavioral Medicine PLLC	New York	New York	United States	10036
8	University of Cincinnati	Cincinnati	Ohio	United States	45219
9	Family Psychiatry of The Woodlands	The Woodlands	Texas	United States	77381
10	Clinic of Child Psychiatry St. Nikolas	Sofia		Bulgaria	1431
11	MHAT Targovishte	Targovishte		Bulgaria	7700
12	Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.	Barranquilla		Colombia	080020
13	E.S.E. Hospital Mental de Antioquia	Bello		Colombia	051053
14	Centro de Investigacion del Sitema Nervioso CISNE	Bogotá		Colombia	1111666
15	Instituto Colombiano Sistema Nervioso Clinica Monserrat	Bogotá		Colombia	250051
16	Psynapsis Salud Mental SA	Pereira		Colombia	660003
17	Centro para la Medicina y de Asistencia Medica Especializada S.C.	Culiacán		Mexico	80230
18	Instituto de Investigacion Clinica AC	Durango		Mexico	34000
19	Consultorio de Medicina Especializada del Sector Privado	Guadalajara		Mexico	44690
20	Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra	Guanajuato		Mexico	37000
21	Iecsi S.C.	Monterrey		Mexico	64310
22	CIT Neuropsique	Monterrey		Mexico	64610
23	Instituto de Informacion e Investigacion en Salud Mental AC	Monterrey		Mexico	64710
24	Medical Care and Research S.A. de C.V.	Mérida		Mexico	97070
25	BLIND Investigaciones SC	San Luis Potosí		Mexico	78213
26	Socola Psychiatric Institute Iasi	Iaşi		Romania	700282
27	Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti	Timişoara		Romania	300230
28	State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"	Arkhangel'sk		Russian Federation	163530
29	Kazan State Medical University KSMU	Kazan		Russian Federation	420012
30	SBHI Specialized Clinical Psychiatric Hospital 1	Krasnodar		Russian Federation	350007
31	Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"	Lipetsk		Russian Federation	399083
32	Joint-Stock Company Scientific Centre of Personalized Medicine	Moscow		Russian Federation	105082
33	SBHI of Moscow Region "Central Clinical Psychiatric Hospital"	Moscow		Russian Federation	127083
34	Clinical Psychiatry Hospital #1 of Nizhniy Novgorod	Nizhny Novgorod		Russian Federation	603155
35	State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary	Roshchino		Russian Federation	188820
36	Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko	Saint Petersburg		Russian Federation	190121
37	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	192019
38	City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova	Saint Petersburg		Russian Federation	197341
39	Center for Medical Rehabilitation named after S.S. Mnukhin	Saint-Petersburg		Russian Federation	197022
40	GBUZ Samara Regional Clinical Psychiatric Hospital	Samara		Russian Federation	443016
41	State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"	Saratov		Russian Federation	410028
42	Smolensk State Medical University	Smolensk		Russian Federation	214019
43	LLC Podderzhka	Stavropol		Russian Federation	355038
44	LLC Clinic "Sto Let"	Tomsk		Russian Federation	634014
45	Stavropol Regional Psychiatric hospital #2	Tonnel'nyy		Russian Federation	357034
46	Yaroslavl Regional Psychiatric Hospital	Yaroslavl Region		Russian Federation	634009
47	Clinic.Neuro.Psych.Child.Youth	Belgrad		Serbia	11000
48	Institute for Mental Health	Belgrad		Serbia	11000
49	Clinic for psychiatry, KCV	Novi Sad		Serbia	21000
50	Regional Psychonevrological Hospital #3	Ivano-Frankivsk		Ukraine	76011
51	SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"	Kharkiv		Ukraine	61068
52	State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine	Kharkov		Ukraine	61153
53	Kherson Regional Institution of Mental Care	Kherson		Ukraine	73488
54	SI Research Institute of Psychiatry of MoH of Ukraine	Kyiv		Ukraine	04108
55	Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital	Lviv		Ukraine	79021
56	Odesa Regional Medical Centre of Mental Health	Odesa		Ukraine	65006
57	Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"	Vinnytsia		Ukraine	21018

Sponsors and Collaborators

Gedeon Richter Plc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gedeon Richter Plc.

ClinicalTrials.gov Identifier:

NCT03817502

Other Study ID Numbers:

RGH-MD-20
2018-004006-26

First Posted:

Jan 25, 2019

Last Update Posted:

Mar 7, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Cariprazine

Study Results

No Results Posted as of Mar 7, 2022