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

> **NCT03434041** · PHASE3 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 252 (actual)

## Conditions studied

- Depressive Disorder, Treatment-Resistant

## Interventions

- **DRUG:** Esketamine 56 mg
- **DRUG:** Esketamine 84 mg
- **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:** NCT03434041
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-05-25
- **Primary completion:** 2021-04-13
- **Final completion:** 2021-04-13
- **Target enrollment:** 252 (ACTUAL)
- **Last updated:** 2025-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03434041

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03434041, "A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT03434041. Licensed CC0.

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