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
NCT ID: NCT03887715
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6800 participants
INTERVENTIONAL
2019-09-26
2030-12-31
Brief Summary
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Detailed Description
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After completing the 12 month endpoint in the RCT portion of the study, all RECOVER subjects will transition into the prospective, open-label, longitudinal portion of the study. Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint.
After completion of enrollment in the RCT portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. These subjects will participate in the study for approximately 5 years.
The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development (CED) decision entitled "Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
Group will have VNS activated 2 weeks post implant.
Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Control
Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Interventions
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Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Conway, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Candace Green
Role: primary
Michael Howell
Role: primary
Bobby Shih
Role: primary
Melissa Escamirosa
Role: primary
Zoe Durkin
Role: primary
Alexis Archer
Role: primary
Yohana Lima
Role: primary
Carlos Bussey
Role: primary
Kailee Kenworthy
Role: primary
Carmen Torres
Role: primary
Elyssa Sisko
Role: primary
Jason R Fritz
Role: primary
Susan Fowler
Role: primary
Sinéad Quinn
Role: primary
Laryssa McCloud
Role: primary
Jennifer Kane
Role: primary
Linda Skaggs
Role: primary
Freeda Baber
Role: primary
Amanda White
Role: primary
Oladele Owasoyo, PhD
Role: primary
Jasli Bonilla
Role: primary
Bryce Lund
Role: primary
Catherine Schuessler
Role: primary
Kayla Thoen
Role: primary
Rachel Johnson
Role: backup
Katherine Fickert
Role: primary
Christopher Sinkler
Role: primary
Mary Beth Haug
Role: primary
Amanda Brouk
Role: primary
Anita Broeker
Role: primary
Lisa Ludwig
Role: primary
Nancy Gilbert, APRN
Role: primary
Michelle Rainka, PharmD
Role: primary
Tatiana Jimenez-Knight
Role: primary
Mariah Garcia
Role: primary
Esha Talati, BS
Role: primary
Lisa Cottone
Role: primary
Anne-Marie Duchemin
Role: primary
Brooke Bhattacharya, MS
Role: primary
Michelle Matukewicz, MHR
Role: primary
Stephanie Terranella
Role: primary
Zoha Babar
Role: backup
Joanna Zheng
Role: primary
Morgan Dancy
Role: primary
Anna Raines Guidry
Role: primary
Tyler Wilson
Role: primary
Tara Upchurch
Role: backup
Hila Abush Segev, PhD
Role: primary
Peter Thompson (PI), MD
Role: primary
Marcela Carbajal Tamez
Role: primary
Asad Islam (PI), MD
Role: primary
Brian Mickey (PI), MD, PhD
Role: primary
Sarah Kwon
Role: backup
Maryann Hollen
Role: primary
David L Dunner (PI), MD
Role: primary
Allison Chen
Role: primary
Suzanne Holroyd, MD
Role: primary
Rick Stauffacher
Role: primary
References
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Aaronson ST, Conway CR, Gordon C, Lee YL, George MS, Zajecka J, Riva-Posse P, Dunner DL, Macaluso M, Rosenquist PB, Mickey BJ, Sheline YI, Hristidis VC, Brown H, Kriedt CL, Tran Q, Bunker MT, Sackeim HA, Rush AJ. Prognostic and Prescriptive Predictors of Treatment Response to Adjunctive VNS Therapy in Major Depressive Disorder: A RECOVER Trial Report. J Clin Psychiatry. 2025 Jul 14;86(3):25m15850. doi: 10.4088/JCP.25m15850.
de Leon VC, Allen RM, Quevedo J, Riva-Posse P, Aaronson ST, Berger MA, Zajecka J, Banov MD, Manu LM, Sheline YI, Farrington J, Eloge JC, Beard J, Kriedt CL, Gott BM, Brown H, Bunker MT, Lee YL, Rush AJ, Sackeim HA, Conway CR. Suicide characteristics in patients with marked treatment-resistant major depressive disorder: A RECOVER trial report. J Affect Disord. 2025 Apr 1;374:619-629. doi: 10.1016/j.jad.2024.12.072. Epub 2024 Dec 24.
Conway CR, Aaronson ST, Sackeim HA, Duffy W, Stedman M, Quevedo J, Allen RM, Riva-Posse P, Berger MA, Alva G, Malik MA, Dunner DL, Cichowicz I, Luing H, Zajecka J, Nahas Z, Mickey BJ, Kablinger AS, Kriedt CL, Bunker MT, Lee YL, Shy O, Majewski S, Olin B, Tran Q, Rush AJ. Clinical characteristics and treatment exposure of patients with marked treatment-resistant unipolar major depressive disorder: A RECOVER trial report. Brain Stimul. 2024 Mar-Apr;17(2):448-459. doi: 10.1016/j.brs.2024.03.016. Epub 2024 Apr 2.
Related Links
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CMS Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression
Other Identifiers
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LND-300
Identifier Type: -
Identifier Source: org_study_id