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

This is a study looking at how safe and effective the investigational drug (AXS-05) is in treating patients who have been diagnosed with major depressive disorder (depression) and have not had an adequate treatment response to previous treatment. Participation is voluntary and the study site will make sure you understand everything before you sign the consent form.

Overview:

This study examines the safety and effectiveness of the investigational drug (AXS-05) in treating patients who have been diagnosed with major depressive disorder. This medication is administered to patients who did not have a positive response to previous treatment attempts.

Study information:

This study is classified as randomized (participants are chosen by chance for treatment), double-blind (the type of treatment given is not known by either investigators or participants), and active-controlled (standard treatment given to control group, treatment group receives experimental treatment). Up to 10 visits are required over a period of approximately 15 weeks. The study is divided into 3 parts: a screening period of up to 2 weeks, a 6 week period (Period 1), and another six-week period (Period 2). Patients who successfully complete screening enter Period 1 and receive bupropion sustained released (SR), a commonly marketed drug approved by the FDA to treat depression. At the end of Period 1, some participants could continue into Period 2 based on the reaction to the drug administered in Period 1. If the doctor confirms eligibility to enter into Period 2, the participant can then decide whether to continue to be a part of this study. If they move forward with the study, they either continue to receive bupropion SR (the same drug and dose taken in Period 1) or, at some point during the 6 weeks, they are switched to AXS-05 (a combination of bupropion and dextromethorphan – the investigational study drug). There is no placebo in this study.

Location:

Study participants need to attend in person in Miami, FL.

Inclusion Criteria:

The investigators allow individuals, between 18 and 65, who have been diagnosed with major depressive disorder (depression) and have not had a positive response to previous treatment. Patients who fail two or more antidepressant therapies are often referred to as having Treatment Resistant Depression (TRD).

Exclusion Criteria:

Those not eligible for this study are women who are pregnant, nursing, or planning on becoming pregnant. Certain medications/treatments and other medical conditions are not allowed. To see who qualifies, visit our website at www.trdstudy.com to take a short questionnaire. All inquiries are confidential.