Abstract
BackgroundDepressive illness is associated with significant adverse consequences for patients and their families, and for society. Clinical challenges are encountered in the management of patients suffering from depression whether they are designated difficult-to-treat or treatment-resistant. Prospective serial depression treatment trials have shown that less than 40% of patients with major depressive disorder remit with an initial pharmacotherapy trial, and a progressively smaller proportion of patients remit with each subsequent trial. For patients who suffer from difficult-to-treat depression (DTD), treatments should focus on patient-centred symptom control, patient functioning, and improving patient quality of life. Among the treatment options for patients with DTD is Vagus Nerve Stimulation (VNS) Therapy. VNS Therapy involves intermittent electrical stimulation of the left cervical vagus nerve and has been shown to be efficacious for long-term management of patients with DTD.MethodsRESTORE-LIFE is a prospective, observational, multi-site, global post-market study intended to assess short-, mid-, and long-term effectiveness and efficiency outcomes in a ‘real-world’ setting among patients with DTD treated with adjunctive VNS Therapy. A minimum of 500 patients will be implanted with a VNS Therapy System at up to 80 global sites. Eligible patients will participate in a baseline visit between 1 and 6 weeks before device implant and will be followed for a minimum of 36 months and a maximum of 60 months. The diagnosis of depression and comorbid disorders will be determined using the Mini-International Neuropsychiatric Interview (MINI). The primary endpoint is response rate, defined as a decrease of ≥50% in Montgomery Åsberg Depression Rating Scale (MADRS) total score from baseline to 12 months post-implant.DiscussionA standardized approach in the management of DTD may not be appropriate for the treatment of such a complex heterogenous patient population. This study has been designed to evaluate whether VNS Therapy meaningfully improves and sustains clinical and depressive symptom outcomes in patients with DTD. This study will investigate the durability of VNS response in DTD and utility of VNS for long-term disease management of DTD. In addition, the study results will potentially clarify clinical, functional, and health economic questions in a real-world patient population with DTD.Trial registrationClinicalTrials.gov NCT03320304. Registered 25 October 2017
Highlights
Depressive illness is associated with significant adverse consequences for patients and their families, and for society
This study has been designed to evaluate whether Vagus Nerve Stimulation (VNS) Therapy meaningfully improves and sustains clinical and depressive symptom outcomes in patients with difficult-to-treat depression (DTD)
Pharmacotherapy with antidepressant drugs is usually the first-line treatment for major depression and prospective serial depression treatment trials have demonstrated that about 40% of patients will not achieve and sustain remission with an initial pharmacotherapy trial, and a progressively smaller proportion of patients remit with each subsequent trial, until the remission rate after a fourth antidepressant trial is between 10 and 15% [8,9,10]
Summary
Depressive illness is associated with significant adverse consequences for patients and their families, and for society. Prospective serial depression treatment trials have shown that less than 40% of patients with major depressive disorder remit with an initial pharmacotherapy trial, and a progressively smaller proportion of patients remit with each subsequent trial. VNS Therapy involves intermittent electrical stimulation of the left cervical vagus nerve and has been shown to be efficacious for long-term management of patients with DTD. Depression is associated with a high burden of disease and has significant adverse consequences for patients, their families, and for society due to impaired daily functioning, impaired social relationships, and financial burdens [2, 3]. Several neurostimulation strategies ─ principally electroconvulsive therapy (ECT) ─ are available for individuals who are insufficiently responsive to pharmacotherapy and/or psychosocial interventions, with clinicians reserving ECT for patients with psychotic depression or when an immediate response to treatment is warranted [12]
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