A Trial of AXS-05 in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Detailed Description
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This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Official Title
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AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder

Conditions
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Depression, Major Depressive Disorder

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age 18 - 65 Currently meets DSM-5 criteria for MDD Body Mass Index between 18 and 40 kg/m^2, inclusive Key Exclusion Criteria: Suicide risk History of treatment resistance in current depressive episode History of electroconvulsive therapy, 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05<br>AXS-05 (bupropion and dextromethorphan) oral tablets | Drug: AXS-05<br>* Oral AXS-05 tablets, taken daily for 6 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo oral tablets to match AXS-05 | Drug: Placebo<br>* Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MADRS Total Score From Baseline to Week 6 | The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Depressive Disorder, Major, Bupropion, Dextromethorphan, MDD, Dopamine Reuptake Inhibitor, AXS-05, NMDA Receptor Antagonist, Central Nervous System, CNS, Sigma-1 Receptor Agonist, Nicotinic Acetylcholine Receptor Antagonist, Norepinephrine Reuptake Inhibitor, Glutamate Modulator, Axsome Therapeutics, GEMINI, Serotonin Reuptake Inhibitor