# 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

> **NCT02417064** · PHASE3 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 346 (actual)

## Conditions studied

- 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)

## Key facts

- **NCT ID:** NCT02417064
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-08-10
- **Primary completion:** 2018-02-20
- **Final completion:** 2018-02-20
- **Target enrollment:** 346 (ACTUAL)
- **Last updated:** 2025-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02417064

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02417064, "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". Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/clinical/NCT02417064. Licensed CC0.

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