NCT04971291

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder
• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	AXS-05	AXS-05 taken twice daily for 6 weeks
DRUG	Bupropion SR	Bupropion taken twice daily for 6 weeks

Timeline

• Start date: 2021-04-14
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2021-07-21
• Last updated: 2021-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study