# 54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

> **NCT03039192** · PHASE3 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 226 (actual)

## Conditions studied

- Depressive Disorder, Major

## Interventions

- **DRUG:** Esketamine
- **OTHER:** Placebo
- **OTHER:** Standard of Care

## Key facts

- **NCT ID:** NCT03039192
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-06-09
- **Primary completion:** 2018-12-18
- **Final completion:** 2018-12-18
- **Target enrollment:** 226 (ACTUAL)
- **Last updated:** 2025-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03039192

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03039192, "54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT03039192. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*