Wells

Researchers are evaluating the use of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for patients with difficult to treat depression, including those with treatment resistant depression. This study focuses on individuals diagnosed with unipolar or bipolar disorder experiencing chronic or recurrent depression who have not responded well to standard psychiatric treatments. The diagnosis and any associated conditions are confirmed using the Mini International Neuropsychiatric Interview (MINI). Patients will receive an implant of the VNS Therapy System, which includes an implantable generator, lead, and external programming system designed to stimulate the vagus nerve. Enrollment is planned for up to 500 patients across about 80 sites worldwide, with a baseline visit scheduled between 1 and 6 weeks before device implantation. After implantation, participants will be followed for at least 36 months and up to 60 months, with the study ending once the last participant completes 36 months of follow-up. During the study, participants will attend outpatient clinic visits regularly and complete various evaluations as outlined in the study protocol. Researchers will measure outcomes such as the reduction in depression severity using the Montgomery Åsberg Depression Rating Scale (MADRS), looking for at least a 50% decrease from baseline to 12 months after implant. The study aims to assess the short, mid, and long-term effectiveness and efficiency of VNS Therapy as an adjunctive treatment for this patient population.