Vagus Nerve Stimulation for Treatment-Resistant Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• UAB Huntsville Regional Medical Center
  Huntsville, Alabama, United States Recruiting
• ATP Clinical Research, Inc.
  Costa Mesa, California, United States Recruiting
• Salma Health
  La Jolla, California, United States Recruiting
• Keck Hospital of USC
  Los Angeles, California, United States Recruiting
• Mindful Behavioral Health
  Boca Raton, Florida, United States Recruiting

+51 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Charles Conway, MD — Washington University School of Medicine
• Study coordinator: Laura Yates, BSN
• Email: laura.yates@livanova.com
• Phone: 281-228-7200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EEG-Guided TMS for Adults With Depression

  This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07862205

• Ketamine plus behavioral activation therapy for treatment-resistant depression

  This study tests whether adding behavioral activation therapy to ketamine treatment helps adults with treatment-resistant depression feel better than ketamine alone.

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• Ketamine-assisted psychotherapy for treatment-resistant depression in adults

  This open-label program tests intravenous ketamine combined with psychotherapy to see if it helps adults with treatment-resistant depression.

  Recruiting Senz · Doorn, Utrecht · NCT07706478

• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• ipRGCs as biomarkers to predict TMS response in major depressive disorder

  This study tests whether retinal cells called ipRGCs can predict who will respond to TMS in treatment-resistant depression.

  Recruiting Polytechnic Institute of Porto · Porto, Porto District · NCT07474974

• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

  This trial tests whether a single-day, robot-guided brain stimulation plus NRX-101 can help adults with treatment-resistant depression compare to sham stimulation and placebo.

  Recruiting at 3 sites Phase 2/3 NeuroRx, Inc. · Sarasota, Florida and 2 other locations · NCT07227103

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.