VNS for Bipolar Depression
(RECOVER Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing whether VNS Therapy, which sends electrical impulses to the vagus nerve, can reduce depression symptoms in patients who haven't responded to other treatments. The study will observe the effects of VNS therapy over a year. Vagus nerve stimulation (VNS) is a recognized treatment for severe treatment-resistant depression and has shown promising results.
Will I have to stop taking my current medications?
The trial requires that you maintain a stable medication regimen for at least four weeks before the device is implanted, so you should not stop taking your current medications.
What data supports the effectiveness of the treatment Vagus Nerve Stimulation (VNS) Therapy System for depression?
Is vagus nerve stimulation safe for humans?
Vagus nerve stimulation (VNS) is generally considered safe for humans, with studies showing it is well-tolerated and has a low rate of serious side effects. Common side effects are related to the stimulation itself and can often be managed by adjusting the device. There are no adverse cognitive effects, and it can be used alongside other treatments without causing drug interactions.36789
How does vagus nerve stimulation differ from other treatments for depression?
Vagus nerve stimulation (VNS) is unique because it involves a device that stimulates the vagus nerve, which is different from typical drug treatments. It is particularly used for severe depression that doesn't respond to standard treatments, and it works by potentially altering brain activity related to mood regulation.1241011
Research Team
Charles Conway, MD
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for adults with treatment-resistant depression, which means they've tried at least four different treatments without success. They should be currently in a major depressive episode that's lasted for two years or more, or have had at least four episodes of major depression. Participants must not change their medications for four weeks before getting the VNS device and can't join if they have certain cognitive disorders, a history of rapid cycling bipolar disorder, schizophrenia, other psychotic disorders, or current suicidal thoughts.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Participants are implanted with the VNS Therapy device
Treatment
Active VNS Therapy treatment or no stimulation control for 12 months
Open-label extension
All subjects transition to open-label VNS Therapy, including control group activation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- VNS Therapy® System (Vagus Nerve Stimulation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
LivaNova
Lead Sponsor