Home › Trials › NCT03887715

Vagus Nerve Stimulation for Treatment-Resistant Depression

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

Not applicable Interventional LivaNova · NCT03887715

This study is testing if Vagus Nerve Stimulation can help people with treatment-resistant depression feel better when added to their current treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment6800 (estimated)
Ages18 Years and up
SexAll
SponsorLivaNova Industry-sponsored
Locations98 sites (Birmingham, Alabama and 97 other locations)
Trial IDNCT03887715 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an adjunctive treatment for patients with treatment-resistant depression (TRD). Participants will be randomly assigned to receive either active VNS therapy or a no stimulation control after device implantation. The study will assess changes in depressive symptoms over a 12-month period using various depression assessment tools. Following the initial phase, participants will have the option to continue in an open-label study for up to five years.

Who should consider this trial

Good fit: Ideal candidates are adults with major depressive disorder who have experienced multiple episodes and have not responded to at least four prior treatments.

Not a fit: Patients with a history of psychotic disorders or rapid cycling bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from treatment-resistant depression.

How similar studies have performed: Previous studies have shown promise for VNS therapy in treating depression, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Treatment Resistant DepressionVNSDepressionTRD
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.