Depression

The primary efficacy endpoint is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Day 28 for REL-1017 as compared to placebo.

The primary objective of this study is to collect both active and passive study watch and phone application data, which aims to capture mental health status, in subjects participating in the RECOVER clinical trial (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).

The primary objective of this study is to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing at least a 50% reduction in baseline depressive symptom severity, based on Montgomery Åsberg Depression Rating Scale (MADRS) total score, at 12 months from randomization.