Clinical Trial 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 DepressionNational Clinical Trial Number:
NCT03887715Contact Information
Clinical Trial Protocol Description:
The purpose of this study is to investigate Vagus Nerve Stimulation (VNS) for people with difficult-to-treat bipolar depression. VNS is a device implanted during an outpatient surgical procedure. It is implanted just below the collarbone and connected to a nerve in the neck. You will probably be able to go home the same day. Treatment will be assigned randomly (stimulation or no stimulation).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Are currently depressed.
- Have bipolar depression that has lasted for at least two years or recurred several times in your life.
- Have tried at least 4 depression treatments that did not help you enough.
- Are receiving at least one mood stabilizing medication.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
John Zajecka, MD
Contact Information
Linda Skaggs
Clinical Trial Location
RUSH University Medical Center