Effectiveness and efficiency of VNS Therapy as adjunctive therapy in patients with difficult to treat depression (RESTORE-LIFE)
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 (across Europe) 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.
Participation in the Restore-Life study is only available to individuals for whom there has been a clinical decision to proceed with VNS and funding has been agreed for the treatment. In Newcastle, this requires individuals to have been referred to, and assessed by, the Regional Affective Disorders Service. The service takes NHS referrals from consultant psychiatrists only.
To view a video on the RESTORE-life study from our recent CPD event click here.