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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
Sponsor: LivaNova
Summary
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6800
Start Date
2019-09-26
Completion Date
2030-12-31
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Locations (98)
University of Alabama at Birmingham
Birmingham, Alabama, United States
UAB Huntsville Regional Medical Center
Huntsville, Alabama, United States
Access Multi Specialty Medical Clinic, Inc
Burlingame, California, United States
CMB Clinical Trials
Colton, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Kaizen Brain Center
La Jolla, California, United States
Keck Hospital of USC
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
SF-CARE, Inc.
San Rafael, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Sunrise Research Institute
Boca Raton, Florida, United States
Mindful Behavioral Health
Boca Raton, Florida, United States
Medycal Research, Inc
Brooksville, Florida, United States
Galiz Research LLC
Hialeah, Florida, United States
Florida Behavioral Psych
Largo, Florida, United States
Segal Trials Corporate
Lauderhill, Florida, United States
Central Miami Medical Institute, LLC
Miami, Florida, United States
Clintex Research Group, Inc.
Miami, Florida, United States
Research Center Of Florida, Inc
Miami, Florida, United States
Ocean Blue Medical Research Center
Miami Springs, Florida, United States
APG Research, LLC
Orlando, Florida, United States
Nova Psychiatry Inc.
Orlando, Florida, United States
Florida Center for TMS
Orlando, Florida, United States
Millenia Psychiatry & Research, Inc
Orlando, Florida, United States
Quantum Laboratories Inc.
Pompano Beach, Florida, United States
Advanced Mental Health Care Inc.
Royal Palm Beach, Florida, United States
Florida Center for TMS
Saint Augustine, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Psychiatric Specialty Center
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia, Augusta University
Augusta, Georgia, United States
PACT Atlanta LLC
Decatur, Georgia, United States
IACT Health
Grayson, Georgia, United States
Psych Atlanta
Marietta, Georgia, United States
Pearl Health Clinic
Ammon, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Joliet Center For Clinical Research
Joliet, Illinois, United States
AMR- Baber Research, Inc.
Naperville, Illinois, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Neuroscience Research Institute
Winfield, Illinois, United States
Advanced Research Institute, Inc.
Indianapolis, Indiana, United States
Beacon Medical Group Behavioral Health
South Bend, Indiana, United States
University Of Kansas Cancer Center
Kansas City, Kansas, United States
Sheppard Pratt Health System, Inc.
Baltimore, Maryland, United States
Clinical Insights
Glen Burnie, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
Andrew Bishop, MD
Jackson, Mississippi, United States
University of Missouri
Columbia, Missouri, United States
Psychiatric Care and Research
O'Fallon, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
PsychCare Consultants Research
St Louis, Missouri, United States
Alivation Research, LLC
Lincoln, Nebraska, United States
Healthy Perspective
Nashua, New Hampshire, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University of New Mexico - Psychiatric Center
Albuquerque, New Mexico, United States
Dent Neurological Institute
Amherst, New York, United States
Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
Buffalo, New York, United States
Trinity Medical
Lewiston, New York, United States
Hapworth Research Inc.
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
State University Of New York Upstate Medical University
Syracuse, New York, United States
ManuMind Interventional Psychiatry
Woodbury, New York, United States
The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health
Cary, North Carolina, United States
Mindpath Care Centers
Raleigh, North Carolina, United States
Wake Forest University Health Science
Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Signature Research Associates, Inc.
Fairlawn, Ohio, United States
Charak Center for Health and Wellness
Garfield Heights, Ohio, United States
NPC Research
Oklahoma City, Oklahoma, United States
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, United States
Scranton Medical Institutes
Moosic, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Neuroscience and TMS Treatment Center
Brentwood, Tennessee, United States
UT Health Austin, Mulva Clinic for the Neurosciences
Austin, Texas, United States
BioBehavioral Research of Austin
Austin, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Texas Tech University Health Science Center
El Paso, Texas, United States
The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders
Houston, Texas, United States
Houston Clinical Trials
Houston, Texas, United States
Northpointe Psychiatry
Lewisville, Texas, United States
Rise Clinical Research, LLC
Missouri City, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Neuropsychiatric Associates, Plc
Woodstock, Vermont, United States
Carilion Clinic
Roanoke, Virginia, United States
Center For Anxiety and Depression
Mercer Island, Washington, United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, United States
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, United States
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States