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

This study is looking at a treatment called **VNS Therapy®** for people with treatment-resistant depression. *VNS Therapy* stands for *Vagus Nerve Stimulation*, which involves using a device to send mild electrical pulses to your vagus nerve, a nerve in your neck that helps control mood. The study wants to see if this therapy works better than not having any stimulation at all.

Participants will have a device implanted and will be divided into two groups: one group will receive the stimulation, and the other will not for the first year. After a year, everyone will receive the stimulation. The study will last up to five years for some participants.

To join, you must have experienced depression for at least two years, tried at least four treatments that didn’t work, and be stable on your current medication for at least four weeks. You can’t join if you have certain mental health conditions or are currently suicidal.

• Study length can be up to 5 years.
• Participants need to have a device implanted.
• Some can receive VNS Therapy after one year.