# A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

> **NCT03852160** · PHASE3 · WITHDRAWN · sponsor: **Janssen-Cilag International NV**

## Conditions studied

- Depressive Disorder, Treatment-Resistant

## Interventions

- **DRUG:** Esketamine 28 mg
- **DRUG:** Esketamine 56 mg
- **DRUG:** Esketamine 84 mg
- **DRUG:** Placebo
- **DRUG:** Escitalopram
- **DRUG:** Sertraline
- **DRUG:** Duloxetine
- **DRUG:** Mirtazapine
- **DRUG:** Agomelatine
- **DRUG:** Bupropion
- **DRUG:** Trazodone Prolonged Release

## Key facts

- **NCT ID:** NCT03852160
- **Lead sponsor:** Janssen-Cilag International NV
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2019-12-01
- **Primary completion:** 2021-07-25
- **Final completion:** 2021-07-25
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study
- **Last updated:** 2025-04-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03852160

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03852160, "A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression". Retrieved via AI Analytics 2026-07-19 from https://api.ai-analytics.org/clinical/NCT03852160. Licensed CC0.

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