Study Phase 2

A Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose Frequency Study of Ketamine in Subjects With Treatment-resistant Depression

  • PDF icon for CSR Summary CSR Summary CSR(s) for this product are publicly available on Health Canada's website - https://clinical-information.canada.ca/search/ci-rc
  • Globe symbol for NCT Number NCT01627782
  • Notebook for Primary Citation Primary Citation Trial has yet to be published
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous SystemEnrollment68% Female67.2%% WhiteN/A
Product ClassNMDA receptor antagonistSponsor Protocol NumberKETIVTRD2002Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)43.9

Supporting Documentation

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

Approved Data Requests Associated with this Trial

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