A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

  • STATUS
    Not Recruiting
  • participants needed
    350
  • sponsor
    Axsome Therapeutics, Inc.
Updated on 31 March 2021

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.

Details
Condition Treatment Resistant Major Depressive Disorder
Treatment Bupropion, AXS-05
Clinical Study IdentifierNCT02741791
SponsorAxsome Therapeutics, Inc.
Last Modified on31 March 2021

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