~2289 spots leftby Feb 2028

VNS for Bipolar Depression

(RECOVER Trial)

Recruiting at 57 trial locations
CC
Overseen byCharles Conway, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: LivaNova
Disqualifiers: Psychotic disorders, Schizophrenia, Bipolar, Dementia, others
No Placebo Group
Approved in 3 Jurisdictions

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?

Research shows that Vagus Nerve Stimulation (VNS) has been studied for over 20 years and may help people with severe, hard-to-treat depression. It has been approved for adults with treatment-resistant depression, and long-term studies suggest it can have an antidepressant effect.12345

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

CC

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

Patients must maintain a stable medication regimen for at least four weeks before device implantation.
The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.
I have been diagnosed with major depression twice in the last 45 days.
See 5 more

Exclusion Criteria

I have never had rapid cycling bipolar disorder.
I am not currently participating in another clinical trial for drugs or devices.
You have been diagnosed with schizophrenia or schizoaffective disorder at any point in your life.
See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants are implanted with the VNS Therapy device

2 weeks

Treatment

Active VNS Therapy treatment or no stimulation control for 12 months

12 months

Open-label extension

All subjects transition to open-label VNS Therapy, including control group activation

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • VNS Therapy® System (Vagus Nerve Stimulation)
Trial OverviewThe study is testing whether using Vagus Nerve Stimulation (VNS) as an additional treatment helps reduce symptoms of severe depression compared to no stimulation control after one year. Patients are randomly assigned to either receive active VNS Therapy or be part of the control group that does not receive stimulation.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Group will have VNS activated 2 weeks post implant.
Group II: ControlPlacebo Group1 Intervention
Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

LivaNova

Lead Sponsor

Trials
66
Recruited
31,100+

Vladimir A. Makatsaria

LivaNova

Chief Executive Officer since 2024

Bachelor of Arts in Physiology, Master of Healthcare Administration, and Master of Business Administration from the University of Minnesota

Dr. Deanna Wilke

LivaNova

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

Vagus Nerve Stimulation (VNS) has shown promising long-term antidepressant effects when combined with standard treatment in over 1100 patients with difficult-to-treat depression, particularly after 12 months of stimulation.
A recent randomized trial did not show immediate benefits from VNS, suggesting that longer treatment durations are necessary to fully assess its efficacy and that new metrics are needed to evaluate clinically meaningful improvements.
The Long and Winding Road of Vagus Nerve Stimulation: Challenges in Developing an Intervention for Difficult-to-Treat Mood Disorders.Sackeim, HA., Dibué, M., Bunker, MT., et al.[2022]
Vagus nerve stimulation (VNS) is a promising device-based therapy for treatment-resistant depression, which is a significant issue affecting both healthcare costs and patient well-being.
Understanding the initiation, implantation, and monitoring of VNS treatment is crucial for psychiatric nurses to improve care for patients suffering from this challenging condition.
Vagus nerve stimulation for severe depression.Rado, J., Janicak, PG.[2019]
Vagus nerve stimulation (VNS) therapy is FDA-approved for treatment-resistant depression in adults and has shown long-term antidepressant effects based on clinical studies.
The paper also explores the potential use of VNS therapy for treatment-resistant depression in adolescents and children, indicating its broader applicability beyond just adult patients.
Vagus nerve stimulation: can it be used in adolescents or children with treatment-resistant depression?Yu, ZJ., Weller, RA., Sandidge, K., et al.[2021]

References

The Long and Winding Road of Vagus Nerve Stimulation: Challenges in Developing an Intervention for Difficult-to-Treat Mood Disorders. [2022]
Vagus nerve stimulation for severe depression. [2019]
Vagus nerve stimulation: can it be used in adolescents or children with treatment-resistant depression? [2021]
[Vagus nerve stimulation. A potential therapy for chronic/recurrent depression?]. [2006]
Systematic review and meta-analysis of vagus nerve stimulation in the treatment of depression: variable results based on study designs. [2022]
Vagus nerve stimulation in chronic treatment-resistant depression: preliminary findings of an open-label study. [2019]
Effectiveness and safety of vagus nerve stimulation for severe treatment-resistant major depression in clinical practice after FDA approval: outcomes at 1 year. [2012]
Vagus Nerve Stimulation for Major Depressive Episodes. [2015]
[Vagus nerve stimulation therapy in epilepsy patients: long-term outcome and adverse effects: a retrospective analysis]. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The antidepressant mechanism of action of vagus nerve stimulation: Evidence from preclinical studies. [2021]
11.North Macedoniapubmed.ncbi.nlm.nih.gov
Vagus Nerve Stimulation. [2020]