VNS Therapy® System Versus No Stimulation for Treatment-Resistant Depression

Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc

Study Contact

Name: Bashar Asir

Annalee Ellis

Email Address: UTMoodDisorders@uth.tmc.edu

Phone number: 713-486-2567

713-486-2527

This study is currently looking for people who:

• Are 18 years or older
• Have bipolar disorder and currently experiencing depression

Study Description:

This study aims to investigate vagus nerve stimulation (VNS) as an antidepressant treatment for people with bipolar disorder, whose depressive symptoms did not respond to medications. VNS is an FDA-approved neural stimulation treatment which involves surgically placing a small implant in the neck near the vagus nerve that sends mild electrical pulses to the areas of the brain associated with mood control. This process may reduce symptoms of depression. Participation in this study lasts for five years. The first year is a placebo-controlled phase, meaning some participants may not receive the treatment initially, but eventually, all participants will be treated.

All participants will be compensated for their time.