Study Phase 4

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupAntidepressantsChemical SubgroupOther AntidepressantsCondition StudiedDepressive Disorder, Major
Sponsor Protocol Number54135419TRD4005Enrollment477Data PartnerJohnson & Johnson% Female59.7%Mean/Median Age (Years)45.3% White86.1%

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

Disclaimer

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