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
Launched by LIVANOVA · Mar 21, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called VNS Therapy® for people who have depression that hasn't improved with other treatments. The goal is to see if this therapy can help reduce the severity of depression symptoms more effectively than not using the therapy at all, after 12 months. Participants in the study will be randomly assigned to either receive the VNS therapy or to a control group that does not receive any stimulation.
To be eligible for this trial, participants need to have been diagnosed with major depressive disorder for at least two years, or have had at least four episodes of depression. They should also have tried at least four different treatments that didn’t work for them. Importantly, participants must be stable on their current medications for at least four weeks before starting the trial. Throughout the study, participants can expect regular check-ins to assess their symptoms and overall well-being. This trial is currently looking for participants aged 65 to 74, and it aims to provide valuable insights into a new treatment option for those struggling with treatment-resistant depression.
Gender
ALL
Eligibility criteria
- Inclusion 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.
- Exclusion Criteria:
- • 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.
About Livanova
Livanova is a global medical technology company specializing in innovative solutions for the treatment of neurological and cardiovascular diseases. With a commitment to advancing patient care, Livanova develops cutting-edge devices and therapies that enhance the quality of life for individuals suffering from complex medical conditions. The company focuses on research and development, collaborating with healthcare professionals and institutions to conduct clinical trials that validate the safety and efficacy of its products. Livanova's dedication to innovation is driven by a passion for transforming healthcare through technology, ultimately aiming to improve outcomes for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Birmingham, Alabama, United States
Charleston, South Carolina, United States
Saint Louis, Missouri, United States
Columbia, Missouri, United States
Chicago, Illinois, United States
Atlanta, Georgia, United States
San Diego, California, United States
Syracuse, New York, United States
New York, New York, United States
Kansas City, Kansas, United States
Dallas, Texas, United States
Glen Burnie, Maryland, United States
Tampa, Florida, United States
Stony Brook, New York, United States
Springfield, Illinois, United States
Cleveland, Ohio, United States
Madison, Wisconsin, United States
Flowood, Mississippi, United States
Costa Mesa, California, United States
Staten Island, New York, United States
Neptune, New Jersey, United States
Mercer Island, Washington, United States
Skokie, Illinois, United States
Amherst, New York, United States
Huntington, West Virginia, United States
Saint Louis, Missouri, United States
Joliet, Illinois, United States
Roanoke, Virginia, United States
Los Angeles, California, United States
Columbus, Ohio, United States
Garfield Heights, Ohio, United States
Buffalo, New York, United States
El Paso, Texas, United States
Miami Springs, Florida, United States
Orlando, Florida, United States
Austin, Texas, United States
Santa Ana, California, United States
Ann Arbor, Michigan, United States
Lincoln, Nebraska, United States
Oklahoma City, Oklahoma, United States
Naperville, Illinois, United States
Colton, California, United States
Lewisville, Texas, United States
New York, New York, United States
Grayson, Georgia, United States
Fairlawn, Ohio, United States
Pompano Beach, Florida, United States
Burlingame, California, United States
La Jolla, California, United States
San Rafael, California, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Brooksville, Florida, United States
Hialeah, Florida, United States
Largo, Florida, United States
Lauderhill, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Royal Palm Beach, Florida, United States
Saint Augustine, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Ammon, Idaho, United States
Winfield, Illinois, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
O'fallon, Missouri, United States
Albuquerque, New Mexico, United States
Lewiston, New York, United States
Winston Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Moosic, Pennsylvania, United States
Brentwood, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Missouri City, Texas, United States
Salt Lake City, Utah, United States
Woodstock, Vermont, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Raleigh, North Carolina, United States
Nashua, New Hampshire, United States
Huntsville, Alabama, United States
Cary, North Carolina, United States
Patients applied
Trial Officials
Charles Conway, MD
Principal Investigator
Washington University School of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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