Evaluation of Deep Brain Stimulation (DBS) in Participants with Major Depression Disorder for safety and benefit.
Official Title
A prospective, double-blind, randomized, multi-center, clinical investigation. Patients will be randomized to a treatment (active DBS) or control group (delayed-stimulation DBS)
Purpose
The purpose of this research study is to evaluate whether adding stimulation of the subcallosal cingulate white matter (or SCCwm), using the investigational Abbott’s Infinity™ Deep Brain Stimulation (DBS) system, as a primary treatment of Major Depressive Disorder (MDD) is safe and beneficial.
Could this study be right for you?
- Diagnosed with MDD
- Current major depressive episode
- Willing to discontinue antidepressant treatments
- Otherwise medically stable