Study Phase 2

A Double-Blind, Doubly-Randomized, Placebo-Controlled Study of Intranasal Esketamine in an Adaptive Treatment Protocol to Assess Safety and Efficacy in Treatment-Resistant Depression (SYNAPSE)

  • PDF icon for CSR Summary CSR Summary CSR(s) for this product are publicly available on Health Canada’s website -
  • Globe symbol for NCT Number NCT01998958
  • Notebook for Primary Citation Primary Citation
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaBehaviors and Mental DisordersEnrollment108% Female50.9%% White44.4%
Product ClassNMDA receptor antagonistSponsor Protocol NumberESKETINTRD2003Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)44.6

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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