An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
Status:
Enrolling by invitation
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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.