How Do I Qualify?
If you are suffering from depression, you may qualify for the AXS-05-MDD-401 study.
The AXS-05-MDD-401 study is looking for people who:*
- Are 18-65 years old
- Are currently experiencing symptoms of depression (see symptom examples inside)
*Additional eligibility criteria apply
If you meet these criteria, the AXS-05-MDD-401 study may be of interest to you.
What is Depression?
Major Depressive Disorder (MDD), often referred to simply as depression, is a disorder characterized by feelings of sadness and a loss of interest or pleasure in daily activities. It can also be characterized by feelings of hopelessness or helplessness. Symptoms can impair your functioning at work or school, your social life and other important areas of your life.
Symptoms Of Depression
People in a depressive episode may experience some or all of the following symptoms, most of the day, nearly every day, for at least two weeks:1
•Persistent sadness
•Feelings of hopelessness
•Feelings of irritability or restlessness
•Feelings of guilt or worthlessness
•Loss of interest or pleasure in hobbies and activities
•Decreased energy or fatigue
•Difficulty concentrating, remembering, or making decisions
•Difficulty sleeping or oversleeping
•Changes in appetite or unplanned weight changes
Not everyone who is depressed experiences the symptoms listed below and this is not an exhaustive list.
About This Study
This study is intended to assess the effectiveness of AXS-05 compared to bupropion in preventing relapse of depressive symptoms in people who have responded to treatment with AXS-05. AXS-05 is not approved for the prevention of relapse and its use in this study is investigational
The study will last up to 41 weeks, consisting of an up to 4-week screening period, a 10-week open-label period where you will receive AXS-05, a 26-week randomization period where you will have a 50/50 chance of receiving AXS-05 or bupropion and a 1-week follow up. Qualified participants will receive study-related care and investigational medication at no cost. Your depression and overall health will be monitored by a team of healthcare professionals and study staff. Compensation for your time and travel may be available.
Why Participate?
Clinical research participation is an important part of developing new treatments. To assess the safety and effectiveness of new drugs, research requires people like you to volunteer and help.
Participation in a clinical research study is completely voluntary, and you may withdraw from a clinical research study at any time for any reason. There is always some risk associated with participation. If you have questions about this study, contact your local study center.
