Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)

Study Identifier
RAP-MD-33
CT.gov Identifier
NCT03614156
EudraCT Identifier
2018-000064-28
EUCTIS ID
Not available
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Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Depression
    • Study Drug
  • Rapastinel
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - * Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32 * If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test
    Exclusion Criteria:
    - * DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1 * Lifetime history of meeting DSM-5 criteria for: * 1.Schizophrenia spectrum or other psychotic disorder * 2.Bipolar or related disorder * 3.Major neurocognitive disorder * 4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study * 5.Dissociative disorder * 6.Posttraumatic stress disorder * 7.MDD with psychotic features * Significant suicide risk, as judged by the Investigator

    Protocol Summary

    The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).

    Study Locations

    Location
    Status
    Location
    Alea Research
    Phoenix, Arizona, United States, 85012
    Status
    Not applicable
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    California Pharmaceutical Research Institute
    Anaheim, California, United States, 92804
    Status
    Not applicable
    Location
    Synergy Research San Diego
    National City, California, United States, 91950
    Status
    Not applicable
    Location
    Excell Research Inc.
    Oceanside, California, United States, 92056
    Status
    Not applicable
    Location
    NRC Research Institute
    Orange, California, United States, 92868
    Status
    Not applicable
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