To evaluate the safety and efficacy of Deep Brain Stimulation for patients with MDD, who have failed to respond to at least 4 treatments in the current episode. The primary outcome assessment will occur at 6 months and all patients will be followed-up for 1 year.
The study will compare group 1 who will be implanted with the device and activated for stimulation and group 2 (the control group) who will be implanted with the device but will not receive active stimulation for the first six months of the study. This study will also aim to describe the effects of DBS on measures of regional brain metabolic activity using electroencephalography (EEG) and PET (positron emission tomography) scanning.
The study is ongoing.
More details can be found on the BROADEN Study website (external link).
Professor Keith Matthews