A Phase 2 interventional study of AXS-05 and Bupropion SR in Major Depressive Disorder and Treatment Resistant Depression, sponsored by Axsome Therapeutics, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Axsome Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 312 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Axsome Therapeutics, Inc. is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 11 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
45 mg dextromethorphan-105 mg bupropion
Drug: AXS-05
150 mg bupropion
Drug: Bupropion SR
AXS-05 taken twice daily for 6 weeks
Bupropion taken twice daily for 6 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
Time frame: Change from Baseline to Week 6
Plan to share: No
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Axsome Therapeutics, Inc.