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

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder, Treatment Resistant Depression

Intervention / Treatment
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* Drug: AXS-05
* Drug: Bupropion SR


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Provided written informed consent to participate in Study AXS-05-301 Has treatment-resistant depression, defined as an inadequate response to 2 or 3 prior ADTs Body mass index (BMI) between 18 and 40 kg/m2, inclusive Key Exclusion Criteria: Suicide risk Treatment with any investigational drug within 6 months History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05<br>45 mg dextromethorphan-105 mg bupropion | Drug: AXS-05<br>* AXS-05 taken twice daily for 6 weeks<br>|
| Active Comparator: Bupropion SR<br>150 mg bupropion | Drug: Bupropion SR<br>* Bupropion taken twice daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AXS-05, Axsome, NMDA receptor