Deep Brain Stimulation for Major Depressive Disorder

Study Summary

This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major depressive disorder who have failed at least 4 treatments in the current episode. The primary outcome assessment will occur at 6 months: however, all patients will be followed for 1 year. A total of 201 patients will be randomized from up to 20 sites. Each potential patient will be pre-screened according to the inclusion/exclusion criteria. A narrative of what study participation entails, will be used to educate potential participants on study requirements. Prior to on-site baseline evaluations, the patient will sign the informed consent. Patients will then undergo 3 baseline evaluations, with each of these evaluations to occur no less than 2 weeks apart from each other. The first 2 baseline visit evaluations will be performed by separate psychiatrists in order to confirm the patient's diagnosis. All patients will be scheduled for surgery, to occur no less than two weeks and no more than 1 month after final baseline evaluation, to implant the ANS Libra® Deep Brain Stimulation system. After device implantation, patients will be randomly assigned to 1 of 2 groups in a 2:1 ratio (Active Treatment Group \& Control Group). After system implant (Week 0), the patient will return to clinic approximately 2 weeks after surgery for evaluation and treatment randomization into either Group 1 or Group 2 (Group 1 = Active Treatment Group; Group 2 = Control Group). Patient will then return to clinic for subsequent evaluations at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 1 year post system implantation.

Primary Outcome

The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.

Interventions

• DEVICE Deep Brain Stimulation, Libra Deep Brain Stimulation System