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A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
NCT06223880 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06223880
The ClinicalTrials.gov registry entry for NCT06223880 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06223880 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06223880?
The interventions under investigation include: AXS-05 (DRUG), Bupropion (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06223880?
This trial is sponsored by Axsome Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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