search
Back to results

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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
Gedeon Richter Plc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • ProScience Research Group
  • Atlanta Center for Medical Research
  • Atlanta Behavioral Research, LLC
  • Bloomfield Hills MI
  • Precise Research Centers
  • UB Department of Psychiatry
  • Manhattan Behavioral Medicine PLLC
  • University of Cincinnati
  • Family Psychiatry of The Woodlands
  • Clinic of Child Psychiatry St. NikolasRecruiting
  • MHAT TargovishteRecruiting
  • Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.Recruiting
  • E.S.E. Hospital Mental de AntioquiaRecruiting
  • Centro de Investigacion del Sitema Nervioso CISNERecruiting
  • Instituto Colombiano Sistema Nervioso Clinica MonserratRecruiting
  • Psynapsis Salud Mental SARecruiting
  • Centro para la Medicina y de Asistencia Medica Especializada S.C.Recruiting
  • Instituto de Investigacion Clinica ACRecruiting
  • Consultorio de Medicina Especializada del Sector Privado
  • Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la ParraRecruiting
  • Iecsi S.C.Recruiting
  • CIT NeuropsiqueRecruiting
  • Instituto de Informacion e Investigacion en Salud Mental ACRecruiting
  • Medical Care and Research S.A. de C.V.Recruiting
  • BLIND Investigaciones SCRecruiting
  • Socola Psychiatric Institute Iasi
  • Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si AdolescentiRecruiting
  • State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
  • Kazan State Medical University KSMU
  • SBHI Specialized Clinical Psychiatric Hospital 1
  • Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
  • Joint-Stock Company Scientific Centre of Personalized Medicine
  • SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
  • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
  • State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
  • Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
  • 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 Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
  • Center for Medical Rehabilitation named after S.S. Mnukhin
  • GBUZ Samara Regional Clinical Psychiatric Hospital
  • State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
  • Smolensk State Medical University
  • LLC Podderzhka
  • LLC Clinic "Sto Let"
  • Stavropol Regional Psychiatric hospital #2
  • Yaroslavl Regional Psychiatric Hospital
  • Clinic.Neuro.Psych.Child.YouthRecruiting
  • Institute for Mental HealthRecruiting
  • Clinic for psychiatry, KCVRecruiting
  • Regional Psychonevrological Hospital #3
  • SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
  • State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
  • Kherson Regional Institution of Mental Care
  • SI Research Institute of Psychiatry of MoH of Ukraine
  • Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
  • Odesa Regional Medical Centre of Mental Health
  • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cariprazine 1.5 mg/d

Cariprazine 4.5 mg/d

Placebo

Arm Description

Cariprazine capsules, oral administration, once daily.

Cariprazine capsules, oral administration, once daily.

Matching placebo capsules, oral administration, once daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2019
Last Updated
December 15, 2022
Sponsor
Gedeon Richter Plc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03817502
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gedeon Richter Plc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine 1.5 mg/d
Arm Type
Experimental
Arm Description
Cariprazine capsules, oral administration, once daily.
Arm Title
Cariprazine 4.5 mg/d
Arm Type
Experimental
Arm Description
Cariprazine capsules, oral administration, once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules, oral administration, once daily.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine capsules, oral administration, once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules, oral administration, once daily.
Primary Outcome Measure Information:
Title
Change from baseline in PANSS total score at Week 6
Description
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.
Time Frame
Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balázs Lázár
Phone
+36 1 432 6437
Email
RA.ctaRichter@richter.hu
Facility Information:
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Completed
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Completed
Facility Name
Atlanta Behavioral Research, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Withdrawn
Facility Name
Bloomfield Hills MI
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Individual Site Status
Withdrawn
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Withdrawn
Facility Name
UB Department of Psychiatry
City
Buffalo
State/Province
New York
ZIP/Postal Code
142515
Country
United States
Individual Site Status
Withdrawn
Facility Name
Manhattan Behavioral Medicine PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Completed
Facility Name
Family Psychiatry of The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Completed
Facility Name
Clinic of Child Psychiatry St. Nikolas
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Targovishte
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
E.S.E. Hospital Mental de Antioquia
City
Bello
ZIP/Postal Code
051053
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion del Sitema Nervioso CISNE
City
Bogotá
ZIP/Postal Code
1111666
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Instituto Colombiano Sistema Nervioso Clinica Monserrat
City
Bogotá
ZIP/Postal Code
250051
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Psynapsis Salud Mental SA
City
Pereira
ZIP/Postal Code
660003
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro para la Medicina y de Asistencia Medica Especializada S.C.
City
Culiacán
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto de Investigacion Clinica AC
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Consultorio de Medicina Especializada del Sector Privado
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
City
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Iecsi S.C.
City
Monterrey
ZIP/Postal Code
64310
Country
Mexico
Individual Site Status
Recruiting
Facility Name
CIT Neuropsique
City
Monterrey
ZIP/Postal Code
64610
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto de Informacion e Investigacion en Salud Mental AC
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Medical Care and Research S.A. de C.V.
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
BLIND Investigaciones SC
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Socola Psychiatric Institute Iasi
City
Iaşi
ZIP/Postal Code
700282
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
City
Timişoara
ZIP/Postal Code
300230
Country
Romania
Individual Site Status
Recruiting
Facility Name
State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
City
Arkhangel'sk
ZIP/Postal Code
163530
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Kazan State Medical University KSMU
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SBHI Specialized Clinical Psychiatric Hospital 1
City
Krasnodar
ZIP/Postal Code
350007
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
City
Lipetsk
ZIP/Postal Code
399083
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Joint-Stock Company Scientific Centre of Personalized Medicine
City
Moscow
ZIP/Postal Code
105082
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
City
Roshchino
ZIP/Postal Code
188820
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
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
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Center for Medical Rehabilitation named after S.S. Mnukhin
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
GBUZ Samara Regional Clinical Psychiatric Hospital
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLC Podderzhka
City
Stavropol
ZIP/Postal Code
355038
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLC Clinic "Sto Let"
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Stavropol Regional Psychiatric hospital #2
City
Tonnel'nyy
ZIP/Postal Code
357034
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Yaroslavl Regional Psychiatric Hospital
City
Yaroslavl Region
ZIP/Postal Code
634009
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinic.Neuro.Psych.Child.Youth
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Institute for Mental Health
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinic for psychiatry, KCV
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Regional Psychonevrological Hospital #3
City
Ivano-Frankivsk
ZIP/Postal Code
76011
Country
Ukraine
Individual Site Status
Completed
Facility Name
SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Completed
Facility Name
State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
City
Kharkov
ZIP/Postal Code
61153
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Kherson Regional Institution of Mental Care
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
SI Research Institute of Psychiatry of MoH of Ukraine
City
Kyiv
ZIP/Postal Code
04108
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Odesa Regional Medical Centre of Mental Health
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.
IPD Sharing Time Frame
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
IPD Sharing Access Criteria
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.

Learn more about this trial

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

We'll reach out to this number within 24 hrs