Global Study to Evaluate Short, Mid, and Long-Term Effects of Vagus Nerve Stimulation Therapy in Adults with Difficult-to-Treat Depression

What this Trial Is About

Researchers are evaluating the short, mid, and long-term clinical outcomes of Vagus Nerve Stimulation VNS Therapy as an additional treatment for patients with difficult to treat depression, including those with treatment resistant depression. The study focuses on adults diagnosed with unipolar or bipolar disorder who have chronic or recurrent depression that has not responded well to standard psychiatric treatments. Depression diagnosis and comorbid conditions will be confirmed using the Mini International Neuropsychiatric Interview MINI. Participants will receive a VNS Therapy System, which includes an implantable generator, lead, and external programming system for vagus nerve stimulation. The study will enroll at least 500 patients across up to 80 sites worldwide. Each participant will have a baseline visit 1 to 6 weeks before device implantation, followed by regular follow-ups for a minimum of 36 months and up to 60 months after implantation. During the study, participants will attend outpatient clinic visits to complete various evaluations and assessments. Researchers will measure depression symptoms using the Montgomery sberg Depression Rating Scale MADRS and other tools over an average of 4 years. They will also track quality of life, patient function, suicidality, cognition, anxiety, and changes in antidepressant treatments. Safety and tolerability will be monitored through the incidence of treatment-emergent adverse events.

A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.