Medtronic, Inc. is sponsoring an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression. Depression is a mood disorder and a serious medical condition that affects millions of Americans. Depressive symptoms may include loss of interest in things typically enjoyed; decreased energy levels; difficulty concentrating or making decisions; restlessness; and feelings of pessimism, hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form of depression characterized by failure to respond to traditional forms of treatment, such as antidepressant medications and electroconvulsive therapy. Treatment-resistant depression significantly impacts quality of life, productivity, and is a major contributor of disability world-wide.

This randomized, double-blind, sham stimulation-controlled, multi-center, prospective, parallel design study uses deep brain stimulation technology to test whether bilateral stimulation can safely and effectively improve depressive symptoms in patients with treatment-resistant depression. This study will begin with enrollment of 30 participants at 5 sites, with plans to be expanded to approximately 200 people from up to 20 sites in the U.S.

Participants implanted with the device systems will be monitored for 12 months following implant, with long-term follow-up until the device is approved or the study is stopped.

Participants meeting criteria for the study will be implanted with the Reclaim DBS System. Participants in the active group, who will receive active stimulation, will be compared to the control group, who will receive sham stimulation, during the 16-week blinded-treatment phase. All participants will be monitored for changes in depressive symptoms. After the blinded-treatment phase, all participants may receive active stimulation.

Candidates for the trial are adults who have major depressive disorder and have not responded to several treatments for depression. Participants in the study will continue to receive their current antidepressant medications while participating in the trial.

Deep brain stimulation therapy is currently approved for use in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Deep brain stimulation for the treatment of depression is investigational.