A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

Brief summary

The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

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-2

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

802

sponsor

Janssen Research & Development, LLC

conditions

Treatment-resistant Depression

interventions

DRUG: Esketamine (Intranasal Spray); DRUG: Duloxetine (Oral Antidepressant); DRUG: Escitalopram (Oral Antidepressant); DRUG: Sertraline (Oral Antidepressant); DRUG: Venlafaxine Extended Release (XR) (Oral Antidepressant)

start date

2015-09-30

start date type

ACTUAL

primary completion date

2017-10-28

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