VNS Therapy Study
If you're suffering from an episode of depression, or bipolar depression, and have been unsuccessful finding a treatment that is helpful, you may qualify to take part in the RECOVER study.
About
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.
Eligibility Criteria
Inclusion criteria
- Must be at least 18 years of age
- Must have Medicare
- Currently experiencing a major depressive episode during which you have seen an inadequate benefit from at least four antidepressant treatments
- Documented diagnosis of bipolar disorder (most recent episode depressed)
- Stable medication regimen for at least 4 weeks
- Not pregnant or intending to become pregnant
Exclusion criteria
- Currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy
- Prior VNS therapy or deep brain stimulation (DBS) implant
- Diagnosis of substance use disorder without sustained remissions (12 months or longer)
- Treatment with another investigational device or investigational drugs
- Current or lifetime history of psychotic features in any major depressive episode
Primary Investigator
Anita Kablinger, MD, CPI
Program director of Clinical Trials Research with Carilion Clinic Psychiatry and Behavioral Medicine and professor of Medicine at the Virginia Tech Carilion School of Medicine, with more than 25 years of clinical and research experience.
Contact Information
Maryann Hollen
Clinical Research Coordinator
