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NCT04019704 · ClinicalTrials.gov registry record · Phase 3
A Trial of AXS-05 in Patients With Major Depressive Disorder
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 327
- Enrollment target
NCT04019704: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT04019704 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 327 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04019704, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 327 participants
- Enrollment target
Study Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Primary Outcome
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Interventions
- DRUG Placebo
- DRUG AXS-05
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2019-12-05 |
| Phase | Phase 3 |
What the finished NCT04019704 record still lists
NCT04019704 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04019704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04019704 about?
NCT04019704 is a clinical study titled "A Trial of AXS-05 in Patients With Major Depressive Disorder". A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
What is the current status of trial NCT04019704?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 327 participants. The study started on 2019-06-20. Estimated completion is 2019-12-05.
What interventions are being tested in trial NCT04019704?
The interventions under investigation include: Placebo (DRUG), AXS-05 (DRUG).
Who is sponsoring clinical trial NCT04019704?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04019704's enrollment target sits among peer trials
327 1075th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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