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 SystemEnrollment230% Female59.9%% White78.9%
Product ClassPsychoanalepticsSponsor Protocol Number54135419SUI3002Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)40.8

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

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.