A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Brief summary

The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

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

TRANSFORM-1

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

346

sponsor

Janssen Research & Development, LLC

conditions

Treatment-resistant Depression

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

2015-08-10

start date type

ACTUAL

primary completion date

2018-02-20

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