A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Study Identifier
RGH-MD-25
CT.gov Identifier
NCT03573297
EudraCT Identifier
2017-000803-25
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

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, Polish, Russian, Serbian, Ukrainian
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Study Details

Medical Condition
  • Bipolar Disorder
  • Mental Health - Other
  • Depression
    • Study Drug
  • Cariprazine
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria: * Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior); * OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).
    Exclusion Criteria:
    * Four or more episodes of a mood disturbance within the 12 months before Visit 1; * Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.

    Protocol Summary

    1\) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day

    Study Locations

    Location
    Status
    Location
    Woodland International Research Group /ID# 232932
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Woodland Research Northwest, LLC /ID# 232982
    Rogers, Arkansas, United States, 72758-6442
    Status
    Not applicable
    Location
    California Pharmaceutical Research Institute Inc. /ID# 232745
    Anaheim, California, United States, 92804
    Status
    Not applicable
    Location
    Advanced Research Center /ID# 233120
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    CI Trials /ID# 232642
    Bellflower, California, United States, 90706-7079
    Status
    Not applicable
    Location
    Synexus Clinical Research US Inc. /ID# 232743
    Cerritos, California, United States, 90703
    Status
    Not applicable
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