VNS Therapy for Treatment-Resistant Depression

Purpose

The purpose of this study is to track active VNS Therapy treatment in subjects with Treatment-Resistant Depression (TRD) and to better understand the reduction in the severity of baseline TRD symptoms. Data will be collected on your responses to study treatments, quality of life, productivity, and your use of healthcare services. Your participation in this study will consist of evaluations by the study doctor (or his/her designee), who will review your past and current medical and psychiatric history, and several questionnaires which you will complete during several follow-up visits over time. 

Keywords: treatment resistant depression, VNS implant, medicare, surgery, depression, bipolar depression

Study Sites

Keck Hospital of USC, 1500 San Pablo St, Los Angeles, CA 90033

 
  • Men & Women
Age icon
18 +
 
 

If several types of treatment for depression have not worked for you, or have not worked well enough, joining the RECOVER Study could give you a new opportunity to improve your quality of life. 


To see if you are eligible contact Zoe Durkin at Zoe.Durkin@med.usc.edu.

 

Eligibility

Must have

  • -18 years old or older
  • -Current Depressed
  • -Have depression, or bipolar depression, that has last at least two years or has recurred several times.
  • -Have tried at least 4 antidepressant treatments and have not found them helpful.

Things to Consider

Benefits:

  • By joining the RECOVER study, you have a chance of benefiting from an FDA-approved treatment for your depression that is not generally available unless you pay for it yourself.
  • By joining, there is a possibility that your symptoms of depression will improve, or even resolve. You may experience an improved quality of life.
  • Once activated, you will receive a continuous antidepressant therapy that's always with you.
  • By taking part in the study, you might also be helping other people like you to access this treatment in the future.
  • Whichever group you are in, you can continue to use your usual medications or therapies.

Risks / Drawbacks:

  • Whichever group you are in, you'll need a short outpatient surgical procedure to implant the device. 
  • There is a 50/50 chance you will be in Group B. This means that, although you will receive a VNS device, active treatment will be delayed for the first 12 months of the study.
  • The surgical procedure and stimulation from the device may sometimes cause side effects (unwanted changes in your health). Side effects are a risk with all medical procedures.

Compensation/Study Coverage

Study coverage will vary depending on your medicare insurance coverage. Please inquire with the study team. Compensation will be provided for each study visit to help pay for travel and for finishing the questionnaires.

Study Team

Photohandler
Principal Investigator
Ashraf Elmashat

For questions about this study, contact:

  • Research Coordinator Zoe Durkin
  • 1333 San Pablo St, MCH B51A, Los Angeles, CA, 90033
  • 323-422-6625
  • zoe.durkin@med.usc.edu

Research study materials

We respect your privacy!

All the information you give us is stored in a secure, password protected database. All the information that you choose to share will be kept private and confidential. Read University of Southern California's Privacy Policy here.