NCT06223880 A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
| NCT ID | NCT06223880 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 350 participants in total. It began in 2023-12-27 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features * Current major depressive episode of at least 4 weeks in duration Exclusion Criteria: * Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity. * Unable to comply with study procedures * Medically inappropriate for study participation in the opinion of the investigator
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06223880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06223880 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06223880 currently recruiting?
Yes, NCT06223880 is actively recruiting participants. Contact the research team at axs-05-mdd-401@axsome.com for enrollment information.
Where is the NCT06223880 trial being conducted?
This trial is being conducted at Bellflower, United States, Lafayette, United States, Oceanside, United States, Redlands, United States and 11 additional locations.
Who is sponsoring the NCT06223880 clinical trial?
NCT06223880 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 350 participants.