RECRUITING

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

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Conditions

Schizophrenia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2019-06-06
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03817502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * DSM-5 primary diagnosis of schizophrenia.
  2. * Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
  3. * 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).
  4. * CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).
  1. * Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
  2. * Diagnosis of intellectual disability (IQ \< 70).
  3. * 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

Study Contact

Balázs Lázár
CONTACT
+36 1 432 6437
RA.ctaRichter@richter.hu

Study Locations (Sites)

ProScience Research Group
Culver City, California, 90230
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338
United States
Bloomfield Hills MI
Bloomfield Hills, Michigan, 48302
United States
Precise Research Centers
Flowood, Mississippi, 39232
United States
UB Department of Psychiatry
Buffalo, New York, 142515
United States
Manhattan Behavioral Medicine PLLC
New York, New York, 10036
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
United States

Collaborators and Investigators

Sponsor: Gedeon Richter Plc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-06
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2019-06-06
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia