drugset / Trial / NCT03829579

Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

NCT03829579

Expanded access Approved for marketing Janssen Research & Development, LLC

Summary

This is a pre-approval access program (PAAP) for eligible participants. The main purpose of this program is to provide access to esketamine nasal spray to eligible participant with treatment-resistant depression (TRD), who have exhausted all other treatment options, including all alternative treatment options with marketed therapies.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 56 mg Intranasal
Subject Esketamine Other / unclassified 84 mg Intranasal