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NCT03595579 · ClinicalTrials.gov registry record · Phase 2
Assessing Symptomatic Clinical Episodes in Depression
A Phase 2 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT03595579: Completed Phase 2 study, sponsored by Axsome Therapeutics.
NCT03595579 is a Phase 2 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03595579, a Phase 2 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
Primary Outcome
The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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 AXS-05
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2019-01-07 |
| Phase | Phase 2 |
What the finished NCT03595579 record still lists
NCT03595579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which AXS-05 is the first listed.
NCT03595579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03595579 about?
NCT03595579 is a clinical study titled "Assessing Symptomatic Clinical Episodes in Depression". Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
What is the current status of trial NCT03595579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2018-05-30. Estimated completion is 2019-01-07.
What interventions are being tested in trial NCT03595579?
The interventions under investigation include: AXS-05 (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT03595579?
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 NCT03595579's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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