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.
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.
| 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 Identifier | NCT02493868 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 24 January 2021 |
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