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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 months
Awards & highlights
RECOVER Trial Summary
This trial will study whether a brain stimulator can help reduce depression symptoms better than no stimulation.
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.Check my eligibility
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.See study design
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.
RECOVER Trial 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.
RECOVER Trial Timeline
Screening ~ 6 weeks2 visits
Treatment ~ 60 months25 visits
Follow Up ~ 1 months1 visit
Screening ~ 6 weeks
Treatment ~ 60 months
Follow Up ~1 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess all Adverse Events
Clinical Global Impressions Scale - Improvement (CGI-I) Response
Health Outcome Scale (EQ-5D-L) Changes in scores over time
+10 moreRECOVER Trial 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a multitude of research centers within the U.S. that are conducting this clinical trial?
"This medical trial has recruited 65 sites for patient enrollment; with the most prominent being in Saint Augustine, Orlando and South Bend. It is recommended to select a center close by so that travel demands are kept at a minimum if you choose to participate."
Answered by AI
How many participants are involved in this experiment?
"Affirmative. Clinicaltrials.gov notes that this ongoing research project, initially posted on September 26th 2019, is actively enrolling up to 6800 patients from 65 sites across the country."
Answered by AI
Are fresh participants being sought out for this research initiative?
"Affirmative, the clinicaltrials.gov database states that this trial is actively seeking participants. This research endeavour started on September 26th 2019 and was last updated recently in September 2022. 6800 patients are needed to be signed up from 65 sites around the country."
Answered by AI
Who else is applying?
What state do they live in?
New York
Texas
Florida
Other
How old are they?
18 - 65
What site did they apply to?
Seattle Neuropsychiatric Treatment Center
Icahn School of Medicine at Mount Sinai
University of Pennsylvania
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
1
3+
What questions have other patients asked about this trial?
How soon are you starting? How long are the screening visits? How long do screening visits take?
PatientReceived 1 prior treatment
Are there any adverse side effects?
PatientReceived no prior treatments
Why did patients apply to this trial?
Im a broke college student. Help address medical condition. Attempt to get a grip on my Mental Health.
PatientReceived 1 prior treatment
To possibly find something to ease my bipolar symptoms. I wwant to help find procedures that will work for others.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- UT Health Austin, Mulva Clinic for the Neurosciences: < 24 hours
- Healthy Perspective: < 24 hours
- State University Of New York Upstate Medical University: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
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