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An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients — TARGET  

Major Depressive Disorder Clinical Trial

Official title:
A Randomized, Active-Controlled, Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients

Clinical Trial Summary

The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode. The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04971291
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact
Status Enrolling by invitation
Phase Phase 2
Start date April 14, 2021
Completion date July 2021
View Details
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