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NCT04039022 · ClinicalTrials.gov registry record · Phase 3
Open-Label Safety Study of AXS-05 in Subjects With Depression
A Phase 3 study of Depression and Major Depressive Disorder, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 876
- Enrollment target
- 20
- Study locations
NCT04039022: Completed Phase 3 study of Depression and Major Depressive Disorder, sponsored by Axsome Therapeutics.
NCT04039022 is a Phase 3 study of Depression and Major Depressive Disorder that has completed, run by Axsome Therapeutics. The registered enrollment target is 876 participants, above the 785-participant average among 679 other Depression trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04039022, a Phase 3 study of Depression and Major Depressive Disorder, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 876 participants
- Enrollment target
- 20
- Study locations
Study Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Primary Outcome
Types and rates of adverse events
Conditions Studied
Interventions
- DRUG AXS-05 (dextromethorphan and bupropion) oral tablets
Study Locations (20)
California
- Clinical Research Site - Bellflower
- Clinical Research Site - Beverly Hills
- Clinical Research Site - Culver City
- Clinical Research Site - Garden Grove
- Clinical Research Site - Oakland
- Clinical Research Site - Oceanside
- Clinical Research Site - Panorama City
- Clinical Research Site - Redlands
- Clinical Research Site - San Diego
- Clinical Research Site - Sherman Oaks
- Clinical Research Site - Upland
Florida
- Clinical Research Site - Coral Springs
- Clinical Research Site - Hialeah
- Clinical Research Site - Hollywood
- Clinical Research Site - Jacksonville
- Clinical Research Site - Lauderhill
- Clinical Research Site - Miami
Arizona
- Clinical Research Site - Phoenix
Arkansas
- Clinical Research Site - Little Rock
Connecticut
- Clinical Research Site - Cromwell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 876 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2020-10-23 |
| Phase | Phase 3 |
What the finished NCT04039022 record still lists
NCT04039022 is an interventional study that assigns participants to a tested intervention. The registered 876 participants enrollment target is mid-sized for trials with a published cap, above the 785-participant average among 679 other Depression trials with a reported enrollment target (12% higher).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which AXS-05 (dextromethorphan and bupropion) oral tablets is the first listed.
NCT04039022 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04039022 about?
NCT04039022 is a clinical study titled "Open-Label Safety Study of AXS-05 in Subjects With Depression". An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
What is the current status of trial NCT04039022?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 876 participants. The study started on 2019-07-08. Estimated completion is 2020-10-23.
What conditions does trial NCT04039022 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Treatment-Resistant Depression.
What interventions are being tested in trial NCT04039022?
The interventions under investigation include: AXS-05 (dextromethorphan and bupropion) oral tablets (DRUG).
Who is sponsoring clinical trial NCT04039022?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04039022 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04039022's enrollment target sits among peer trials
876 47th of 679 higher than 633 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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