A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)
Official Title
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)Purpose
The purpose of this study is to examine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
The duration of the study will consist over a 5 year period. You will visit the study site approximately 23 times after your implant surgery.
Could this study be right for you?
• Aged 18 years or older
• Must be in a major depressive episode (MDD or bipolar disorder) for ≥ two years or have at least had four episodes of depression including the current episode
• Patients depressive illness meets a minimum criteria of four prior failed treatments of adequate dose and duration