Study of Rapastinel as Monotherapy in Patients With MDD

Study Identifier
RAP-MD-32
CT.gov Identifier
NCT03560518
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
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:
    * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD * Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1 * Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode * 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: * Schizophrenia spectrum or other psychotic disorder * Bipolar or related disorder * Major neurocognitive disorder * 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 * Dissociative disorder * Posttraumatic stress disorder * 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) and 900 milligrams (mg) of Rapastinel, compared to placebo 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, Inc.
    Anaheim, California, United States, 92804
    Status
    Not applicable
    Location
    Collaborative Neuroscience Network
    Garden Grove, California, United States, 92845
    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
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