Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Medtronic, Inc. sponsored 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 used deep brain stimulation technology to test whether active bilateral
 stimulation can safely and effectively improve depressive symptoms in patients with
 treatment-resistant depression compared to sham stimulation.

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

 Candidates for the trial were adults who had major depressive disorder and had not responded
 to several treatments for depression. Participants in the study continued to receive their
 current antidepressant medications while participating in the trial.
Inclusion Criteria:

 -  Consent to participate in screening and study procedures by signing and dating the
 Informed Consent Form

 -  Are diagnosed with major depressive disorder (MDD)

 -  Have tried at least 4 different treatments, for example antidepressant medications,
 combinations of antidepressant medications, and/or electroconvulsive therapy (ECT)

 -  Screening MADRS score ≥ 28

 -  Have had the current major depressive episode persist for at least 2 years

 -  Females, if of child-bearing potential, must be using an acceptable method of birth
 control

 Exclusion Criteria:

 -  Females: Currently pregnant

 -  Currently enrolled in or plan to enroll in any concurrent drug and/or device study
 that may confound the results of this study

 -  Have a neurological condition that may jeopardize the safety or the conduct of the
 study

 -  Have any medical conditions unsuitable for undergoing DBS surgery