A clinical trial to evaluate treatments using Venlafaxine Extended Release (XR) (Oral Antidepressant), Duloxetine (Oral Antidepressant), Sertraline (Oral Antidepressant), Placebo, Esketamine, Escitalopram (Oral antidepressant) for patients with Depressive Disorder, Treatment-Resistant

  • STATUS
    Not Recruiting
  • participants needed
    718
  • sponsor
    Janssen Research & Development, LLC
Updated on 24 January 2021
remission
duloxetine
depressive disorder
antidepressants
depressive symptoms
depressive episode
sertraline
mental disorder
venlafaxine
citalopram
esketamine

Summary

The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.

Description

This is a randomized, double-blind (neither the researchers nor the participant know what treatment the participants is receiving), active-controlled, multicenter (more than 1 study site) study in participants with TRD to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms. The study will consist of 5 phases: Screening/Prospective Observational Phase (4-7weeks) for direct-entry participants only, Open-label Induction Phase (4-weeks) for direct-entry participants only, Optimization Phase (12-weeks; open-label for direct-entry participants and double-blind for transferred-entry participants), Maintenance Phase (variable duration; double-blind for all participants) and Follow-up Phase (2-weeks). Participants' safety will be monitored throughout the study.

Details
Condition Depressive Disorder, Treatment-Resistant
Treatment Placebo, Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant)
Clinical Study IdentifierNCT02493868
SponsorJanssen Research & Development, LLC
Last Modified on24 January 2021

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