A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Official Title
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STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder

Conditions
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Treatment Resistant Major Depressive Disorder

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Currently meets DSM-V criteria for MDD History of inadequate response to 1 or 2 adequate antidepressant treatments Body mass index (BMI) between 18 and 40 kg/m2, inclusive Agree to use adequate method of contraception for the duration of the study Additional criteria may apply 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 Additional criteria may apply

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> | Drug: AXS-05<br>* AXS-05 taken daily for 6 weeks.<br>|
| Active Comparator: Bupropion<br> | Drug: Bupropion<br>* Buproprion taken 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. | MADRS change from Baseline to End of Study (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions-Severity (CGI-S) |  | Baseline to End of Study (6 weeks) | 
| Hamilton Depression Rating Scale - 17 items (HAMD-17) |  | Baseline to End of Study (6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AXS-05, Major Depressive Disorder, Treatment Resistant Depression, TRD, MDD, Axsome, NMDA receptor, Refractory depression, Resistant depression, Depression