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VNS for Bipolar Depression (RECOVER Trial)
N/A
Recruiting
Led By Charles Conway, MD
Research Sponsored by LivaNova
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.
Timeline
Screening 6 weeks
Treatment 60 months
Follow Up 1 month
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from Vagus Nerve Stimulation may include voice changes due to nerve irritation, coughing, sore throat, shortness of breath, tingling sensation in the skin and difficulty swallowing. These side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been in a major depressive episode for over two years or have had at least four episodes.
Select...
I have been in a major depressive episode for over two years or have had at least four episodes.
Select...
I have been diagnosed with major depression twice in the last 45 days.
Timeline
Screening ~ 6 weeks2 visits
Treatment ~ 60 months25 visits
Follow Up ~ 1 month1 visit
Screening ~ 6 weeks
Treatment ~ 60 months
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assess all Adverse Events
Clinical Global Impressions Scale - Improvement (CGI-I) Response
Health Outcome Scale (EQ-5D-L) Changes in scores over time
+10 moreTrial Design
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 Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
LivaNovaLead Sponsor
64 Previous Clinical Trials
25,845 Total Patients Enrolled
Charles Conway, MDPrincipal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
1,223 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had rapid cycling bipolar disorder.I am not currently participating in another clinical trial for drugs or devices.I have tried at least four different treatments for my depression without success.You have been diagnosed with schizophrenia or schizoaffective disorder at any point in your life.You have a history of any other type of mental disorder that causes loss of touch with reality.I have been diagnosed with major depression twice in the last 45 days.I have tried at least four different treatments for my depression without success.I have been in a major depressive episode for over two years or have had at least four episodes.I have a diagnosis of a cognitive disorder like dementia.My medication has been the same for at least 4 weeks before getting a device implanted.My medication has been the same for at least four weeks before getting a device implanted.I have been diagnosed with major depression twice in the last 45 days.You have or have had psychotic symptoms during a major depressive episode.You are currently thinking about or planning to harm yourself.I have been in a major depressive episode for over two years or have had at least four episodes.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 6 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 60 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Bipolar Depression Patient Testimony for trial: Trial Name: NCT03887715 — N/A
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