Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

Study Identifier
RGH-MD-24
CT.gov Identifier
NCT03593213
EudraCT Identifier
2017-000818-34
EUCTIS ID
Not available
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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Bulgarian, Malay, Polish, Serbian, Ukrainian
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Study Details

Medical Condition
  • Schizophrenia
    • Study Drug
  • Cariprazine
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 64 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening). * Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits. * Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5). * Positive and Negative Syndrome Scale (PANSS) total score \>= 70 and \<= 120 at Visit 1 and Visit 2 (Day 1). * Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.
    Exclusion Criteria:
    * Currently meeting DSM-5 criteria for any of the following: * Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders * Bipolar I and II disorder * Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder * History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1. * Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study. * Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.

    Protocol Summary

    1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia

    2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

    Study Locations

    Location
    Status
    Location
    Pillar Clinical Research
    Bentonville, Arkansas, United States, 72712
    Status
    Not applicable
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Woodland Research Northwest, LLC
    Rogers, Arkansas, United States, 72758
    Status
    Not applicable
    Location
    Advanced Research Center, Inc.
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    CITrials - Bellflower
    Bellflower, California, United States, 90706
    Status
    Not applicable
    Location
    Synexus Clinical Research US, Inc.
    Cerritos, California, United States, 90703
    Status
    Not applicable
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