ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.
About this trial
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
Qualifiers
Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
Current major depressive episode of at least 4 weeks in duration
Disqualifiers
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
Trial design
Treatments tested in this trial
- AXS-05
- Bupropion
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov