NCT06223880RecruitingPhase 4
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 16 Jan 2024
- Start date
- 27 Dec 2023
- Primary completion date
- Mar 2026
- Lead sponsor
- Axsome Therapeutics, Inc.
- Diseases
- Depression
- NCT number
- NCT06223880
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 350
- From 27 Dec 2023 to the primary completion date, Mar 2026
- 37 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Who the study is looking for
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.