Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Study Identifier
RAP-MD-99
CT.gov Identifier
NCT03668600
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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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
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Completion of lead-in study * Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator
    Exclusion Criteria:
    * Suicide risk, as determined by meeting any of the following criteria: 1. A suicide attempt within the past year 2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study 3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted. * At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator * Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation * Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

    Protocol Summary

    Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Harmonex Neuroscience Research
    Dothan, Alabama, United States, 36303
    Status
    Not applicable
    Location
    NoesisPharma
    Phoenix, Arizona, United States, 85016
    Status
    Not applicable
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Woodland Research Northwest
    Rogers, Arkansas, United States, 72758
    Status
    Not applicable
    Location
    California Pharmaceutical Research Institute, Inc
    Anaheim, California, United States, 92804
    Status
    Not applicable
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