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

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Study

Study Title: 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

 
Want to learn more? Contact:

https://trdstudy.com
SeeOurWebsite@trdstudy.com
 
Study Website: https://trdstudy.com
Principal Investigator name: See website  

Condition(s) being studied: Depression

 

This study protocol does include a treatment intervention.
(such as medication, talk therapy, or another therapeutic intervention)


Study Description

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. There will be a total of up to 10 visits over a period of approximately 15 weeks. The study will be divided into 3 parts: an up to two-week screening period, a 6-week period (Period 1), and another 6-week period (Period 2). If you successfully complete screening, you will enter Period 1 and receive bupropion sustained released (SR), a currently marketed drug approved by the FDA to treat depression. At the end of Period 1, you may or may not continue into Period 2. If the doctor confirms you are eligible to enter into Period 2, and if you continue to choose to be a part of this study, you will either continue to receive bupropion SR (the same drug and dose you took in Period 1) or at some point during the 6 weeks, you will be switched to AXS-05 (a combination of bupropion and dextromethorphan – the investigational study drug). There is no placebo in this study. We are looking for individuals between 18-65 who have been diagnosed with major depressive disorder (depression) and have not had an adequate treatment response to previous treatment. Patients who fail two or more antidepressant therapies are often referred to as having Treatment Resistant Depression (TRD). You are not eligible for this study if you are pregnant, nursing, or planning on becoming pregnant. Certain medications/treatments and other medical conditions are not allowed. To see if you qualify, visit our website www.trdstudy.com to take a short questionnaire. All inquiries are confidential. If you are eligible, you will be contacted by the closest study site.

What will I do?

In total, you will make up to 10 visits in person. The activities you can expect to complete include, but are not limited to the following: in-person and phone interviews and questionnaires, laboratory tests, urine collections, urine pregnancy tests, physical examinations and vital signs. Study-related care is provided at no cost to participants. Compensation for time and travel may be provided.

Study participants will need to attend in person.

Where is the study being conducted? Miami, FL
Who is sponsoring the study? Axsome Therapeutics  
Internal Review Board Approval Number: AXS1-16-050  
Telephone number: (919) 465-4310  
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