Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817502
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 6, 2019
Estimated Primary Completion Date : December 17, 2022
Estimated Study Completion Date : December 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




Primary Outcome Measures :
  1. Change from baseline in PANSS total score at Week 6 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817502


Contacts
Layout table for location contacts
Contact: Clinical Trials Registry Team 877-277-8566 IR‐CTRegistration@Allergan.com

Locations
Layout table for location information
United States, California
ProScience Research Group Recruiting
Culver City, California, United States, 90230
Contact: Study Coordinator    424-227-8127      
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
Contact: Study Coordinator    404-881-5800      
Atlanta Behavioral Research, LLC Recruiting
Atlanta, Georgia, United States, 30338
Contact: Study Coordinator    770-458-0447      
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
Contact    601-420-5810      
United States, New York
UB Department of Psychiatry Recruiting
Buffalo, New York, United States, 142515
Contact: Study Coordinator    716-898-5940      
Manhattan Behavioral Medicine PLLC Active, not recruiting
New York, New York, United States, 10036
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Study Coordinator    513-558-7700      
United States, Texas
Family Psychiatry of The Woodlands Recruiting
The Woodlands, Texas, United States, 77381
Contact: Study Coordinator    281-367-1015 ext 131      
Bulgaria
Clinic Child Psychiatry St Nikolas Recruiting
Sofia, Bulgaria, 1431
Contact    359 292 30375      
MHAT Targovishte Recruiting
Targovishte, Bulgaria, 7700
Contact: Study Coordinator    359 888 446697      
Sponsors and Collaborators
Allergan
Investigators
Layout table for investigator information
Study Director: Paul Yeung Allergan
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03817502    
Other Study ID Numbers: RGH-MD-20
2018-004006-26 ( EudraCT Number )
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports 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. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
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.
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.
URL: http://www.allerganclinicaltrials.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cariprazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs