Assessing VNS Therapy for Difficult to Treat 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 study evaluates the effectiveness and efficiency of Vagus Nerve Stimulation (VNS) Therapy in patients suffering from difficult to treat depression, specifically those with treatment resistant depression. It involves a real-world patient population diagnosed with chronic or recurrent major depressive episodes who have not responded adequately to standard treatments. A minimum of 500 patients will be implanted with a VNS Therapy System, and their clinical outcomes will be monitored over a follow-up period of 36 to 60 months. The study aims to gather data on short, mid, and long-term effects of this therapy as an adjunctive treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be at least 18 years of age.
* Have a documented primary diagnosis of chronic (\>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.
* Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).
* Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).
* Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)

Exclusion Criteria:

There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.

Where it's running

• AKH Allgemeines Krankenhaus der Stadt Wien
  Vienna, Austria Recruiting
• KU Leuven
  Leuven, Belgium Recruiting
• Universitätsklinikum Bonn
  Bonn, Germany Recruiting
• Universitätsklinikum Köln
  Cologne, Germany Recruiting
• LVR-Hospital Essen
  Essen, Germany Recruiting
• Universitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting

Study contacts

• Principal investigator: Koen Demyttenaere, Prof. — KU Leuven
• Study coordinator: Funda Basdar
• Email: funda.basdar@livanova.com
• Phone: +32 473 97 49 41

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.

  Recruiting Phase 2/3 The Royal's Institute of Mental Health Research · Ottawa, Ontario · NCT07801703

• 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.