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

Status unconfirmed · Phase 2

Conditions studied: Major Depressive Disorder, Treatment Resistant Depression

In brief

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.

Key facts

Study ID
NCT04971291
Run by
Axsome Therapeutics, Inc.
People needed
312
Starts
2021-04-14
Expected to finish
2021-07-01
Last updated by the study team
2021-07-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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