Study Phase 3

A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaBehaviors and Mental DisordersEnrollment719% Female64.8%% White79.7%
Product ClassNMDA receptor antagonistSponsor Protocol NumberESKETINTRD3003Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)46.1

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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