# Open-Label Safety Study of AXS-05 in Subjects With Depression

> **NCT04039022** · PHASE3 · COMPLETED · sponsor: **Axsome Therapeutics, Inc.** · enrollment: 876 (actual)

## Conditions studied

- Major Depressive Disorder
- Treatment Resistant Depression
- Depression

## Interventions

- **DRUG:** AXS-05 (dextromethorphan and bupropion) oral tablets

## Key facts

- **NCT ID:** NCT04039022
- **Lead sponsor:** Axsome Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-07-08
- **Primary completion:** 2020-10-23
- **Final completion:** 2020-10-23
- **Target enrollment:** 876 (ACTUAL)
- **Last updated:** 2022-10-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04039022

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04039022, "Open-Label Safety Study of AXS-05 in Subjects With Depression". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04039022. Licensed CC0.

---

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