A Global PRospective, Multi-cEnter, ObServational post-markeT Study tO assess shoRt, mid and long-term Effectiveness and efficiency of VNS Therapy® as adjunctive therapy in reaL-world patIents with diFficult to treat dEpression (RESTORE-LIFE).
The main aim of this study is to assess short, mid and long -term clinical outcomes in patients with difficult to treat depression (i.e., patients diagnosed with unipolar disorder or bipolar disorder with chronic or recurrent depression who have failed to achieve an adequate response to standard psychiatric management) treated with Vagus Nerve Stimulation (VNS) Therapy.
A minimum of 500 patients will be implanted with VNS therapy. Once implanted with the device, patients will be followed-up for a minimum of 36 months and a maximum of 60 months. Data collected during this study will be used to evaluate changes in clinical symptoms over time in response to adjunctive VNS Therapy.
This study is sponsored by LivaNova and is running across Europe and the UK. Centres involved in delivering the study are: Newcastle University, Kings College London, Belguim, and Germany, with 3 more UK sites due to open by early 2019 (Bristol, Leicester, and Somerset).