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NCT06223880 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
A Phase 4 study of Major Depressive Disorder, sponsored by Axsome Therapeutics.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT06223880: Recruiting Phase 4 study of Major Depressive Disorder, sponsored by Axsome Therapeutics.
NCT06223880 is a Phase 4 study of Major Depressive Disorder that is actively recruiting participants, run by Axsome Therapeutics. The registered enrollment target is 350 participants, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06223880, a Phase 4 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Axsome Therapeutics.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
Conditions Studied
Interventions
- DRUG AXS-05
- DRUG Bupropion
Study Locations (20)
Florida
- Clinical Research Site - Brandon
- Clinical Research Site - Doral
- Clinical Research Site - Hialeah
- Clinical Research Site - Jacksonville
- Clinical Research Site - Miami
- Clinical Research Site - Orlando
- Clinical Research Site - Orlando
- Clinical Research Site - Orlando
California
- Clinical Research Site - Bellflower
- Clinical Research Site - Lafayette
- Clinical Research Site - Oceanside
- Clinical Research Site - Redlands
- Clinical Research Site - Riverside
- Clinical Research Site - San Diego
- Clinical Research Site - Upland
Georgia
- Clinical Research Site - Atlanta
Illinois
- Clinical Research Site - Chicago
Kansas
- Clinical Research Site - Overland Park
Louisiana
- Clinical Research Site - New Orleans
Massachusetts
- Clinical Research Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
What NCT06223880 shows while recruiting
NCT06223880 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which AXS-05 is the first listed.
NCT06223880 names 20 study sites across 7 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06223880 about?
NCT06223880 is a clinical study titled "A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms". This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
What is the current status of trial NCT06223880?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 350 participants. The study started on 2023-12-27. Estimated completion is 2026-03.
What conditions does trial NCT06223880 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06223880?
The interventions under investigation include: AXS-05 (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT06223880?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06223880 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
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 NCT06223880's enrollment target sits among peer trials
350 46th of 282 higher than 237 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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