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

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupAntidepressantsChemical SubgroupOther AntidepressantsCondition StudiedDepressive Disorder, Major
Sponsor Protocol Number54135419SUI3001Enrollment226Data PartnerJohnson & Johnson% Female61.8%Mean/Median Age (Years)39.3% White67.1%

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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