# A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

> **NCT04338321** · PHASE3 · COMPLETED · sponsor: **Janssen-Cilag International NV** · enrollment: 676 (actual)

## Conditions studied

- Depressive Disorder, Major

## Interventions

- **DRUG:** Esketamine 28 mg
- **DRUG:** Esketamine 56 mg
- **DRUG:** Esketamine 84 mg
- **DRUG:** Quetiapine XR 50 mg
- **DRUG:** Quetiapine XR 100 mg
- **DRUG:** Quetiapine XR 150 mg
- **DRUG:** SSRI/SNRI

## Key facts

- **NCT ID:** NCT04338321
- **Lead sponsor:** Janssen-Cilag International NV
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-08-21
- **Primary completion:** 2022-01-20
- **Final completion:** 2022-07-15
- **Target enrollment:** 676 (ACTUAL)
- **Last updated:** 2025-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04338321

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04338321, "A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder". Retrieved via AI Analytics 2026-07-19 from https://api.ai-analytics.org/clinical/NCT04338321. Licensed CC0.

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