Cost-Effectiveness of Vagus Nerve Stimulation for Treating Resistant Depression in Adults A Multicenter, Randomized, Open-Label Study

What this Trial Is About

Depression affects about 17% of people during their lifetime, with many cases becoming resistant to treatment. Treatment-resistant depression TRD often leads to relapse, recurrence, and reduced quality of life, impacting daily functioning and healthcare needs. This trial explores the use of Vagus Nerve Stimulation VNS as a new treatment option for patients with TRD, including those with bipolar disorder, aiming to address the limitations of current therapies like electroconvulsive therapy ECT. The study is a national, multicenter, randomized, controlled trial comparing VNS plus optimal medical treatment to optimal medical treatment alone. Participants will be randomly assigned to either receive VNS along with the best medical treatment BMT or BMT alone. The VNS device is surgically implanted under general anesthesia, involving electrode placement on the vagus nerve and a stimulator under the skin. Following implantation, stimulation settings are adjusted over several months to reach therapeutic levels. Both groups will be followed for 24 months with regular visits, including medical and psychiatric evaluations, while the experimental group undergoes additional neurosurgical and stimulation adjustment visits. Throughout the study, participants will attend multiple scheduled visits for clinical assessments, including evaluations of depression severity, treatment effects, and safety monitoring. Data on cost-utility and efficacy of VNS will be collected at various intervals up to 24 months. The study aims to provide insight into the long-term benefits and economic impact of VNS compared to standard care for treatment-resistant depression.

Treatment Resistant Depression and Vagus Nerve Stimulation