Taking people in United StatesNo phase
Tests a vagus nerve stimulation device added to usual care for treatment-resistant depression
Tests a nerve stimulation device in adults with depression not helped by treatment.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Albuquerque, Amherst, Ammon, Ann Arbor, Atlanta, Augusta, Austin, Baltimore, Birmingham, Boca Raton, Boston, Brentwood, Brooksville, Buffalo, Burlingame, Cary, Charleston, Chicago, Cleveland, Colton, Columbia, Columbus, Costa Mesa, Dallas, Decatur, El Paso, Fairlawn, Flowood, Garfield Heights, Glen Burnie, Grayson, Hialeah, Houston, Huntington, Huntsville, Indianapolis, Jackson, Jacksonville, Joliet, Kansas City, La Jolla, Largo, Lauderhill, Lewiston, Lewisville, Lincoln, Los Angeles, Madison, Marietta, Mercer Island, Miami, Miami Springs, Minneapolis, Missouri City, Moosic, Morgantown, Naperville, Nashua, Neptune City, New York, O'Fallon, Oklahoma City, Orlando, Philadelphia, Pompano Beach, Raleigh, Roanoke, Royal Palm Beach, Saint Augustine, Salt Lake City, San Diego, San Rafael, Santa Ana, Seattle, Skokie, South Bend, Springfield, St Louis, Staten Island, Stony Brook, Syracuse, Tampa, Tulsa, West Palm Beach, Winfield, Winston-Salem, Woodbury, and Woodstock, United StatesSee the 101 sites
Where in United States
- University of New Mexico - Psychiatric CenterAlbuquerque, United StatesNo longer taking part
- Dent Neurological InstituteAmherst, United StatesTaking people
- Pearl Health ClinicAmmon, United StatesNo longer taking part
- Michigan Clinical Research Institute PCAnn Arbor, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Medical College of Georgia, Augusta UniversityAugusta, United StatesTaking people
- UT Health Austin, Mulva Clinic for the NeurosciencesAustin, United StatesTaking people
- BioBehavioral Research of AustinAustin, United StatesNo longer taking part
- Sheppard Pratt Health System, Inc.Baltimore, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Mindful Behavioral HealthBoca Raton, United StatesTaking people
- Sunrise Research InstituteBoca Raton, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesTaking people
- Neuroscience and TMS Treatment CenterBrentwood, United StatesTaking people
- Medycal Research, IncBrooksville, United StatesNo longer taking part
- Erie County Medical Center/State University of New York (SUNY) at Buffalo AffiliateBuffalo, United StatesNo longer taking part
- Access Multi Specialty Medical Clinic, IncBurlingame, United StatesNo longer taking part
- The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC HealthCary, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University Hospitals Case Medical CenterCleveland, United StatesNo longer taking part
- CMB Clinical TrialsColton, United StatesNo longer taking part
- University of MissouriColumbia, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- ATP Clinical Research, Inc.Costa Mesa, United StatesTaking people
- University of Texas, SouthwesternDallas, United StatesTaking people
- PACT Atlanta LLCDecatur, United StatesNo longer taking part
- Texas Tech University Health Science CenterEl Paso, United StatesTaking people
- Signature Research Associates, Inc.Fairlawn, United StatesTaking people
- Precise Research CentersFlowood, United StatesTaking people
- Charak Center for Health and WellnessGarfield Heights, United StatesTaking people
- Clinical InsightsGlen Burnie, United StatesNo longer taking part
- IACT HealthGrayson, United StatesNo longer taking part
- Galiz Research LLCHialeah, United StatesTaking people
- The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood DisordersHouston, United StatesTaking people
- Houston Clinical TrialsHouston, United StatesNo longer taking part
- Marshall University Joan C. Edwards School of MedicineHuntington, United StatesTaking people
- UAB Huntsville Regional Medical CenterHuntsville, United StatesTaking people
- Advanced Research Institute, Inc.Indianapolis, United StatesNo longer taking part
- Andrew Bishop, MDJackson, United StatesNo longer taking part
- Flourish Research - St. AugustineJacksonville, United StatesTaking people
- Joliet Center For Clinical ResearchJoliet, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Salma HealthLa Jolla, United StatesTaking people
- Florida Behavioral MedicineLargo, United StatesNo longer taking part
- Segal Trials CorporateLauderhill, United StatesNo longer taking part
- Trinity MedicalLewiston, United StatesTaking people
- Northpointe PsychiatryLewisville, United StatesNo longer taking part
- Alivation Research, LLCLincoln, United StatesTaking people
- Keck Hospital of USCLos Angeles, United StatesTaking people
- University of WisconsinMadison, United StatesTaking people
- Psych AtlantaMarietta, United StatesTaking people
- Center For Anxiety and DepressionMercer Island, United StatesTaking people
- Central Miami Medical Institute, LLCMiami, United StatesNo longer taking part
- Clintex Research Group, Inc.Miami, United StatesNo longer taking part
- Research Center Of Florida, IncMiami, United StatesNo longer taking part
- Ocean Blue Medical Research CenterMiami Springs, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesTaking people
- Rise Clinical Research, LLCMissouri City, United StatesNo longer taking part
- Scranton Medical InstitutesMoosic, United StatesTaking people
- West Virginia Clinical and Translational Science InstituteMorgantown, United StatesNo longer taking part
- AMR-Baber Research IncNaperville, United StatesTaking people
- Healthy PerspectiveNashua, United StatesTaking people
- Jersey Shore University Medical CenterNeptune City, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Hapworth Research Inc.New York, United StatesNo longer taking part
- Psychiatric Care and ResearchO'Fallon, United StatesTaking people
- NPC ResearchOklahoma City, United StatesNo longer taking part
- Rivus Wellness & Research InstituteOklahoma City, United StatesNo longer taking part
- APG Research, LLCOrlando, United StatesTaking people
- Nova Psychiatry Inc.Orlando, United StatesTaking people
- Florida Center for TMSOrlando, United StatesNo longer taking part
- Millenia Psychiatry & Research, IncOrlando, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Quantum Laboratories IncPompano Beach, United StatesNo longer taking part
- Mindpath Care CentersRaleigh, United StatesNo longer taking part
- Carilion ClinicRoanoke, United StatesTaking people
- dTMS Center, LCCRoyal Palm Beach, United StatesNo longer taking part
- Florida Center for TMSSaint Augustine, United StatesNo longer taking part
- The University of UtahSalt Lake City, United StatesTaking people
- University of California San DiegoSan Diego, United StatesNo longer taking part
- SF-CARE, Inc.San Rafael, United StatesNo longer taking part
- Syrentis Clinical ResearchSanta Ana, United StatesNo longer taking part
- Seattle Neuropsychiatric Treatment CenterSeattle, United StatesTaking people
- Psychiatric Medicine Associates, LLCSkokie, United StatesTaking people
- Beacon Medical Group Behavioral HealthSouth Bend, United StatesNo longer taking part
- Southern Illinois University School of MedicineSpringfield, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- PsychCare Consultants ResearchSt Louis, United StatesNo longer taking part
- Richmond Behavioral AssociatesStaten Island, United StatesNo longer taking part
- Stony Brook University HospitalStony Brook, United StatesNo longer taking part
- State University of New York Upstate Medical UniversitySyracuse, United StatesNo longer taking part
- IPTB Clinical ResearchTampa, United StatesTaking people
- K2 Medical ResearchTampa, United StatesTaking people
- Stedman Clinical TrialsTampa, United StatesNo longer taking part
- University of Oklahoma School of Community MedicineTulsa, United StatesNo longer taking part
- Psychiatric Specialty CenterWest Palm Beach, United StatesNo longer taking part
- Neuroscience Research InstituteWinfield, United StatesNo longer taking part
- Wake Forest University Health ScienceWinston-Salem, United StatesNo longer taking part
- ManuMind Interventional PsychiatryWoodbury, United StatesTaking people
- Neuropsychiatric Associates, PlcWoodstock, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LivaNova
- Trial code
- NCT03887715
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Treatment with another investigational device or investigational drugs; 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.