Study Phase 3

A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT03434041
  • Notebook for Primary Citation Primary Citation Not Yet Available
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupAntidepressantsChemical SubgroupOther AntidepressantsCondition StudiedDepressive Disorder, Treatment-Resistant
Sponsor Protocol NumberESKETINTRD3006Enrollment252Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)37.3% WhiteN/A

Supporting Documentation

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

Approved Data Requests Associated with this Trial

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