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 now · Not applicable

Conditions studied: Treatment Resistant Depression

In brief

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 facts

Study ID

NCT03887715

Run by

LivaNova

People needed

6800

Starts

2019-09-26

Expected to finish

2030-12-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• University Of Kansas Cancer Center — Kansas City, Kansas, United States (enrolling)
• Michigan Clinical Research Institute PC — Ann Arbor, Michigan, United States (enrolling)
• Psych Atlanta — Marietta, Georgia, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Keck Hospital of USC — Los Angeles, California, United States (enrolling)
• IPTB Clinical Research — Tampa, Florida, United States (enrolling)
• Medical College of Georgia, Augusta University — Augusta, Georgia, United States (enrolling)
• AMR- Baber Research, Inc. — Naperville, Illinois, United States (enrolling)
• Psychiatric Medicine Associates, LLC — Skokie, Illinois, United States (enrolling)
• Sheppard Pratt Health System, Inc. — Baltimore, Maryland, United States (enrolling)
• Kaizen Brain Center — La Jolla, California, United States (enrolling)
• Galiz Research LLC — Hialeah, Florida, United States (enrolling)
• Flourish Research - St. Augustine — Jacksonville, Florida, United States (enrolling)
• Florida Behavioral Psych — Largo, Florida, United States (enrolling)
• UAB Huntsville Regional Medical Center — Huntsville, Alabama, United States (enrolling)
• K2 Medical Research — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• ATP Clinical Research, Inc. — Costa Mesa, California, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• APG Research, LLC — Orlando, Florida, United States (enrolling)
• Nova Psychiatry Inc. — Orlando, Florida, United States (enrolling)
• Mindful Behavioral Health — Boca Raton, Florida, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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