A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Status:
Completed
Trial end date:
2020-03-20
Target enrollment:
Participant gender:
Summary
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with
treatment resistant major depressive disorder (MDD).
This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting
of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is
being conducted in subjects with treatment resistant MDD.
Subjects will be considered to have treatment resistant MDD if they have had a historical
inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response
to treatment with bupropion during the open-label, lead-in period.