EMBARC: Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care
Principal Investigator: Melvin McInnis, MD
What is EMBARC?
Our purpose is to assess clinical and biological moderators and mediators (biomarkers) of treatment outcome that may help guide future treatment selection for those diagnosed with Major Depressive Disorder (MDD).
- An extensive screening visit
- Three weeks free of medication
- Biological testing: MRI, EEG, psychological, and blood for genetics
- Either sertraline or placebo for your treatment medications
- Up to $725 compensation
- Ages 18-65 with a diagnosis of Major Depressive Disorder before age 30
- Currently experiencing symptoms of depression
- Willing to be randomized to either sertraline or placebo
Participating in this Study
Why is this study important?
It is our intention to develop a predictive model that integrates the best current evidence to provide personalized treatment for Major Depressive Disorder, which can be further modified as new evidence emerges.
Who can participate?
People between the ages of 18-65 who have been diagnosed with Major Depressive Disorder before the age of 30 and are currently experiencing a depressive episode may be eligible to participate. You must also agree to, and complete, all biomarker procedures which include EEG/psychological testing, MRI, and blood draws.
You may be ineligible for this study if you have a history of non-response or poor tolerability to sertraline or buproprion, or if you are taking medications for general medical condition(s) that cannot be taken with the study medication.
You may also be ineligible if you are currently in therapy that is depression specific, such as Cognitive Behavioral Therapy (CBT) or Interpersonal Psychotherapy of Depression (IPT).
There are other criteria that may exclude you from participating in this research study. Further screening will be completed on the telephone to insure that you are eligible.
What are the risks?
A member of our team will be happy to answer any questions you may have regarding the risks of participation. Sertraline and buproprion are currently FDA approved for the treatment of depression. If you experience a worsening of symptoms that becomes harmful to your safety, you may be exited from the study. We will closely monitor your symptoms throughout the duration of the study. It is important to know that participating in research is completely voluntary and should you decide not to proceed, there will be no penalty to you.
What are the benefits?
Participants will receive a clear research diagnosis and treatment with an experienced clinician at the University of Michigan Depression Center. Close monitoring of symptoms and side effects occurs on a regular basis and you may feel a reduction in the severity of symptoms of depression.
How do I get involved?
Contact our research team by phone or email. We will then provide more information about the study and determine your eligibility for the screening visit over the phone.
Any information shared with our research staff will remain confidential.
877-864-3637 Toll-free or UM-MDDResearch@umich.edu
Study ID: HUM00044057
IRB: IRBMED Date Approved: 9/20/2012
Expiration Date: 1/8/2015