Treatment Resistant Depression study: Vagus Nerve Stimulation
Official title A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT03887715
What this study is testing
- What it's testing
- The study wants to find out if active VNS therapy lowers depression scores more than a device that is not turned on, measured over 12 months.
- Who it's for
- Adults who have depression that has not improved with standard treatments.
- What's involved
- Participants will have a VNS device implanted; some will receive active stimulation while others will have the device left off. They will attend regular clinic visits for safety checks and complete depression questionnaires.
- Time commitment
- The trial lasts about 12 months, with periodic visits for monitoring and assessments.
- Time commitment: about 5 years
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool...
- The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits...
- Patients must maintain a stable medication regimen for at least four weeks before device implantation.
You likely can't join if
- Current or lifetime history of psychotic features in any MDE;
- Current or lifetime history of schizophrenia or schizoaffective disorder;
- Current or lifetime history of any other psychotic disorder;
- Current or lifetime history of rapid cycling bipolar disorder;
- Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
- Current suicidal intent; or
See the full eligibility criteria
- 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'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.
- The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.
- Patients must maintain a stable medication regimen for at least four weeks before device implantation.
- Current or lifetime history of psychotic features in any MDE;
- Current or lifetime history of schizophrenia or schizoaffective disorder;
- Current or lifetime history of any other psychotic disorder;
- Current or lifetime history of rapid cycling bipolar disorder;
- Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
- Current suicidal intent; or
- Treatment with another investigational device or investigational drugs.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Costa Mesa, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Boca Raton, Florida, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Naperville, Illinois, United States
- Skokie, Illinois, United States
- Springfield, Illinois, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Huntsville, Alabama, United States; Costa Mesa, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Boca Raton, Florida, United States and 42 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.