RECOVER – Vagal Nerve Stimulation for Depression

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)

Sponsor: LivaNova

Objectives of this study are to determine 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.
– Up to 1,000 people who have depression or bipolar depression that has been difficult to treat will take part in the study.
– The study will be carried out at up to 100 leading hospitals and medical centers across the United States.
– If you choose to participate, you will not have to pay for VNS Therapy or for any study-related care.
– By participating, you could help many other people with treatment resistant depression to gain access to VNS Therapy in the future.