Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
Current major depressive episode of at least 4 weeks in duration
You may not be if
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
