VNS for Bipolar Depression (RECOVER Trial)
Recruiting in Palo Alto (17 mi)
+57 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: LivaNova
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.
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.
1381011Is 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.
24579What 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.
134611Will 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.
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
I have been in a major depressive episode for over two years or have had at least four episodes.
I have been in a major depressive episode for over two years or have had at least four episodes.
I have been diagnosed with major depression twice in the last 45 days.
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.
Participant Groups
The 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.
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
Research locations nearbySelect from list below to view details:
Beacon Medical Group Behavioral HealthSouth Bend, IN
University of MinnesotaMinneapolis, MN
Massachusetts General HospitalBoston, MA
University of MissouriColumbia, MO
More Trial Locations
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Who is running the clinical trial?
LivaNovaLead Sponsor
References
[Vagus nerve stimulation. A potential therapy for chronic/recurrent depression?]. [2006]Vagus Nerve Stimulation (VNS) is since the 1990 a clinically useful anticonvulsant therapy for treatment-resistant epilepsy. Open acute and longer term data suggest the potential clinical utility of VNS as an antidepressant therapy especially in treatment refractory depression. The vagus nerve has connections to the limbic system and other brain structures which modulate affect. PET studies showed functional changes under VNS in such critical areas, which can explain the mechanisms of action of VMS. Ongoing studies will have to better establish its acute and longer-term efficacy, and specific indications in the treatment of depression.
Vagus nerve stimulation in chronic treatment-resistant depression: preliminary findings of an open-label study. [2019]We evaluated the efficacy and safety of vagus nerve stimulation therapy in the treatment of 11 patients with chronic treatment-resistant depression. Mood was evaluated at frequent intervals over the year following implantation. All measures of depression, including the Hamilton Rating Scale for Depression reduced significantly. The response and remission rates were 55% and 27% respectively at 1 year. Side-effects were common, and some were severe.
Vagus nerve stimulation for severe depression. [2019]Treatment-resistant depression is a serious problem with significant costs in terms of health care dollars and patients' well-being. Vagus nerve stimulation (VNS) is one novel, device-based therapy that may be effective in this population. In this article, we review the evidence to date on the use of VNS in major depression and describe the process of VNS treatment initiation, device implantation, and dosage adjustment and monitoring. It is important for psychiatric nurses to understand the evidence base for and how VNS is used in treatment so they may enhance care of patients with treatment-resistant depression.
Vagus nerve stimulation: can it be used in adolescents or children with treatment-resistant depression? [2021]Vagus nerve stimulation (VNS) therapy has been approved by the US Food and Drug Administration for treatment-resistant depression in patients 18 years of age and older and for intractable epilepsy. Long-term studies suggest VNS has an antidepressant effect in adults. This paper reviews the available clinical data for VNS therapy. Its potential application for treatment-resistant depression in adolescents and children is also discussed.
Effectiveness and safety of vagus nerve stimulation for severe treatment-resistant major depression in clinical practice after FDA approval: outcomes at 1 year. [2012]To describe the outcomes of a consecutive series of depressed patients treated with vagus nerve stimulation (VNS) following US Food and Drug Administration (FDA) approval of this intervention.
Systematic review and meta-analysis of vagus nerve stimulation in the treatment of depression: variable results based on study designs. [2022]To determine the efficacy of vagus nerve stimulation (VNS) for treatment of depression.
[Vagus nerve stimulation therapy in epilepsy patients: long-term outcome and adverse effects: a retrospective analysis]. [2022]Vagus nerve stimulation (VNS) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years. Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown. It is considered to be low in adverse effects.
The antidepressant mechanism of action of vagus nerve stimulation: Evidence from preclinical studies. [2021]Vagus nerve stimulation (VNS) is a proposed neuromodulatory treatment for medically refractory major depression. Although VNS is already used in clinical practice, the underlying mechanism of action remains unknown. The present review provides an overview of the preclinical VNS studies in view of two major hypotheses in depression research: the monoaminergic and the neural plasticity hypothesis of depression.
Vagus Nerve Stimulation for Major Depressive Episodes. [2015]Stimulation of the left vagus nerve is a novel antidepressive therapy that relies upon the vagal projections to the brain stem to modulate brain circuits involved in mood regulation. There is cumulative evidence from prospective and long-term studies that has demonstrated tolerability and effectiveness of vagus nerve stimulation (VNS) in major depressive episodes (MDE). VNS in MDE has the following advantages: symptomatic response (defined as at least a 50% improvement in MDE severity) occurs in at least 15-17% of patients after 10 weeks of VNS treatment and in at least 22-37% of patients after 12 months of VNS treatment, remissions are observed in at least 15-17% of patients after 12 months of treatment, there is a sustained response in 13-27% of patients during 12 months of VNS, and successful maintenance of the initial improvement is observed in a high percentage of patients (73-77% of patients who had meaningful or greater benefit after 3 months of treatment maintained at least meaningful benefit after 12 months of treatment). VNS is a well-tolerated treatment as indicated by the high continuation rates of VNS therapy in the D01 and D02 studies after 12 months of therapy (90-98%) and the low rate of adverse event-related study discontinuations through 12 months or more in these studies (3%). Adverse effects are characterized by the absence of systemic effects associated with drug therapy and are primarily limited to those related to stimulation of the vagus nerve; many of the common adverse effects only occurred when VNS was on with the ability to stop acute stimulation-related adverse effects immediately through the use of magnet deactivation of the VNS device. More importantly, there were no adverse cognitive and psychomotor effects observed with antidepressant drugs and electroconvulsive therapy, no overdose toxicity observed with antidepressant drugs, favorable findings in animal reproductive studies, and an ability to add VNS therapy to antidepressant drug therapy without producing drug-drug interactions. Finally, VNS has high treatment compliance because VNS therapy is programmed to work automatically without the need for action on the patient's part (no pills to swallow).
Vagus Nerve Stimulation. [2020]The vagus nerve stimulation (VNS) is an approach mainly used in cases of intractable epilepsy despite all the efforts. Also, its benefits have been shown in severe cases of depression resistant to typical treatment.
The Long and Winding Road of Vagus Nerve Stimulation: Challenges in Developing an Intervention for Difficult-to-Treat Mood Disorders. [2022]The Vagus Nerve Stimulation (VNS) Therapy System has been studied for more than 20 years in patients with severe, treatment-resistant, chronic mood disorder, i.e., difficult-to-treat depression (DTD). This review distills some of the implications of this research for future therapeutic trials in this population.