VNS Therapy
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.
Category
Mental and Behavioral Health
Age Requirement
Adults (18 years and older)
About This Study
Summary
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.
To be included in VNS Therapy, participants must be / have
- 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 4 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
To be included in VNS Therapy, participants must not be / have
- 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
Keywords
Depression; Therapy
For More About This Study or To Ask About Participation
Additional Information
Program director of clinical trials research with Carilion Clinic Psychiatry and Behavioral Medicine and professor of medicine at Virginia Tech Carilion School of Medicine with more than 25 years of clinical and research experience.
Official title of study
Symmetry VNS DR2-REV3
Funding mechanism
Industry Sponsored by Symmetry VNS DR2-REV3