# Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Pediatric Participants Assessed to be at Imminent Risk for Suicide

> **NCT03185819** · PHASE2 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 147 (actual)

## Conditions studied

- Depressive Disorder, Major

## Interventions

- **DRUG:** Intranasal Placebo
- **DRUG:** Midazolam Placebo Solution
- **DRUG:** Midazolam
- **DRUG:** Esketamine
- **DRUG:** Esketamine
- **DRUG:** Esketamine

## Key facts

- **NCT ID:** NCT03185819
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-10-05
- **Primary completion:** 2023-03-31
- **Final completion:** 2023-03-31
- **Target enrollment:** 147 (ACTUAL)
- **Last updated:** 2025-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03185819

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03185819, "Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Pediatric Participants Assessed to be at Imminent Risk for Suicide". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT03185819. Licensed CC0.

---

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