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

Description

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

Conditions

Schizophrenia

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Culver City

ProScience Research Group, Culver City, California, United States, 90230

Atlanta

Atlanta Center for Medical Research, Atlanta, Georgia, United States, 30331

Atlanta

Atlanta Behavioral Research, LLC, Atlanta, Georgia, United States, 30338

Bloomfield Hills

Bloomfield Hills MI, Bloomfield Hills, Michigan, United States, 48302

Flowood

Precise Research Centers, Flowood, Mississippi, United States, 39232

Buffalo

UB Department of Psychiatry, Buffalo, New York, United States, 142515

New York

Manhattan Behavioral Medicine PLLC, New York, New York, United States, 10036

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45219

The Woodlands

Family Psychiatry of The Woodlands, The Woodlands, Texas, United States, 77381

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

13 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gedeon Richter Plc.,

Study Record Dates

2025-04-01