Recruiting
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.
ClinicalTrials.gov IDNCT03887715
PhaseNA
Enrollment6800
SponsorLivaNova
Age18 Years
SexALL
Conditions studied
Treatment Resistant Depression
About this study
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.
Interventions
- Device: Vagus Nerve Stimulation (VNS) — VNS is an implantable device that delivers stimulation to the vagal nerve.
Primary outcomes
- Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response (12 months post randomization)
- Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response (Baseline up to 12 Months)
- Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission (Baseline up to 12 Months)
- Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response (Baseline up to 12 Months)
- Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission (Baseline up to 12 Months)
- Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response (Baseline up to 12 Months)
- Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission (Baseline up to 12 Months)
- Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission (Baseline up to 12 Months)
Eligibility information
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.
Study locations
- University of Alabama at Birmingham, Birmingham, Alabama 35294 United States
- UAB Huntsville Regional Medical Center, Huntsville, Alabama 35801 United States
- Access Multi Specialty Medical Clinic, Inc, Burlingame, California 94010 United States
- CMB Clinical Trials, Colton, California 92324 United States
- ATP Clinical Research, Inc., Costa Mesa, California 92626 United States
- Kaizen Brain Center, La Jolla, California 92037 United States
- Keck Hospital of USC, Los Angeles, California 90033 United States
- University of California San Diego, San Diego, California 92103 United States
- SF-CARE, Inc., San Rafael, California 94901 United States
- Syrentis Clinical Research, Santa Ana, California 92705 United States
Showing 10 of 101 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.