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
NCT03887715
This study is recruiting at 53 US sites in 26 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Treatment Resistant Depression
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- LivaNova
- Last updated on ClinicalTrials.gov
- June 15, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 2
- University of Alabama at Birmingham · Birmingham, AL
- UAB Huntsville Regional Medical Center · Huntsville, AL
California · 3
- ATP Clinical Research, Inc. · Costa Mesa, CA
- Kaizen Brain Center · La Jolla, CA
- Keck Hospital of USC · Los Angeles, CA
Florida · 8
- Mindful Behavioral Health · Boca Raton, FL
- Galiz Research LLC · Hialeah, FL
- Flourish Research - St. Augustine · Jacksonville, FL
- Florida Behavioral Psych · Largo, FL
- APG Research, LLC · Orlando, FL
- Nova Psychiatry Inc. · Orlando, FL
- IPTB Clinical Research · Tampa, FL
- K2 Medical Research · Tampa, FL
Georgia · 3
- Emory University · Atlanta, GA
- Medical College of Georgia, Augusta University · Augusta, GA
- Psych Atlanta · Marietta, GA
Illinois · 4
- Rush University Medical Center · Chicago, IL
- AMR- Baber Research, Inc. · Naperville, IL
- Psychiatric Medicine Associates, LLC · Skokie, IL
- Southern Illinois University School of Medicine · Springfield, IL
Kansas · 1
- University Of Kansas Cancer Center · Kansas City, KS
Maryland · 1
- Sheppard Pratt Health System, Inc. · Baltimore, MD
Massachusetts · 1
- Massachusetts General Hospital · Boston, MA
Michigan · 1
- Michigan Clinical Research Institute PC · Ann Arbor, MI
Minnesota · 1
- University of Minnesota · Minneapolis, MN
Mississippi · 1
- Precise Research Centers · Flowood, MS
Missouri · 3
- University of Missouri · Columbia, MO
- Psychiatric Care and Research · O'Fallon, MO
- Washington University School of Medicine · St Louis, MO
Nebraska · 1
- Alivation Research, LLC · Lincoln, NE
New Hampshire · 1
- Healthy Perspective · Nashua, NH
New York · 4
- Dent Neurological Institute · Amherst, NY
- Trinity Medical · Lewiston, NY
- Icahn School of Medicine at Mount Sinai · New York, NY
- ManuMind Interventional Psychiatry · Woodbury, NY
Ohio · 2
- The Ohio State University · Columbus, OH
- Charak Center for Health and Wellness · Garfield Heights, OH
Oklahoma · 1
- University of Oklahoma School of Community Medicine · Tulsa, OK
Pennsylvania · 2
- Scranton Medical Institutes · Moosic, PA
- University of Pennsylvania · Philadelphia, PA
South Carolina · 1
- Medical University of South Carolina · Charleston, SC
Tennessee · 1
- Neuroscience and TMS Treatment Center · Brentwood, TN
Texas · 5
- UT Health Austin, Mulva Clinic for the Neurosciences · Austin, TX
- University of Texas Southwestern · Dallas, TX
- Texas Tech University Health Science Center · El Paso, TX
- The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders · Houston, TX
- Northpointe Psychiatry · Lewisville, TX
Utah · 1
- The University of Utah · Salt Lake City, UT
Virginia · 1
- Carilion Clinic · Roanoke, VA
Washington · 2
- Center For Anxiety and Depression · Mercer Island, WA
- Seattle Neuropsychiatric Treatment Center · Seattle, WA
West Virginia · 1
- Marshall University Joan C. Edwards School of Medicine · Huntington, WV
Wisconsin · 1
- University of Wisconsin · Madison, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.