A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

SUSTAIN-1

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

719

sponsor

Janssen Research & Development, LLC

conditions

Depressive Disorder, Treatment-Resistant

interventions

DRUG: Esketamine; DRUG: Placebo; DRUG: Duloxetine (Oral Antidepressant); DRUG: Escitalopram (Oral antidepressant); DRUG: Sertraline (Oral Antidepressant); DRUG: Venlafaxine Extended Release (XR) (Oral Antidepressant)

start date

2015-10-01

start date type

ACTUAL

primary completion date

2018-02-15

has results

true

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters