LivaNova announces a publication in Contemporary Clinical Trials, which details the design for a prospective, multicentre, randomised controlled blinded trial demonstrating the safety and effectiveness of vagus nerve stimulation (VNS) therapy system as adjunctive therapy versus a no stimulation control in subjects with treatment-resistant depression, or the RECOVER clinical study.
RECOVER is currently underway as part of a Coverage with Evidence Development framework of the US Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination process.
“VNS Therapy for treatment-resistant depression has proven to be a safe and effective adjunctive treatment that significantly improves patients’ response and remission rates in this chronically ill population that is difficult to treat,” said Charles R Conway, director of the Washington University Resistant Mood Disorders Center, who serves as principal investigator for RECOVER. “As we continue to gain momentum and recruit patients for this important research, we are pleased to share more detailed information on this study, with the goal of raising awareness among clinicians and patients who could benefit from VNS Therapy.”
Major Depressive Disorder (MDD) is a leading cause of disability, morbidity and mortality worldwide. Even after four adequate courses of antidepressant treatment, one in three patients are left with depressive symptoms that significantly impact their daily functioning. The objectives of the RECOVER study are to confirm, in a randomised controlled blinded trial, the outcomes previously observed and published in a large registry—that VNS therapy has a significant positive effect on baseline depressive symptom severity for patients with treatment-resistant depression (TRD).
“Working with CMS, we designed RECOVER—the largest clinical study of its kind—to further evaluate and confirm the efficacy of VNS Therapy for TRD,” said Bryan Olin, LivaNova senior vice president for Clinical, Quality and Regulatory Affairs. “The goal of the RECOVER study is to strengthen the results reported in previous studies, facilitating a positive National Coverage Determination that improves access to VNS Therapy for TRD patients who do not respond to other antidepressant therapies, potentially transforming their quality of life.”
More information about the RECOVER study is available here.