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
Recruiting · NCT03887715 · Interventional (participants receive a specific treatment) · Lead sponsor: LivaNova
View the official record on ClinicalTrials.gov →Interventions studied
Vagus Nerve Stimulation (VNS)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 32 US states.
- 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
- Flourish Research - St. Augustine - Jacksonville, 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
- dTMS Center, LCC - Royal Palm Beach, Florida, United States
- Florida Center for TMS - Saint Augustine, Florida, United States
- IPTB Clinical Research - Tampa, Florida, United States
- Stedman Clinical Trials - Tampa, Florida, United States
- K2 Medical Research - 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
- Washington University School of Medicine - 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
Showing 60 of 101 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →