Study Phase 3

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide

  • 1 CSR Summary CSR(s) for this product are publicly available on Health Canada’s website - https://clinical-information.canada.ca/search/ci-rc
  • 1 NCT03097133
  • 1 Primary Citation
  • Data Specification Not Available

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaBehaviors and Mental DisordersEnrollment226% Female61.8%% White67.1%
Product ClassNMDA receptor antagonistSponsor Protocol Number54135419SUI3001Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)39.3

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

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