# 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

Clinical trial · Janssen Research & Development, LLC

- Archive id: nct:NCT02417064
- Published: 2015-04-15
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02417064
- Source URL: https://clinicaltrials.gov/study/NCT02417064
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under 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._

## 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

Topics: [Novel Psychiatric Therapeutics](https://space-kitty.com/topics/psychiatric-therapeutics)

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