Assessing VNS Therapy for Difficult to Treat Depression
A Global PRospective, Multi-cEnter, ObServational Post-markeT Study tO Assess shoRt, Mid and Long-term Effectiveness and Efficiency of VNS Therapy® as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression.
This study is testing if Vagus Nerve Stimulation therapy can help people with hard-to-treat depression feel better when other treatments haven't worked.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LivaNova Industry-sponsored |
| Locations | 18 sites (Vienna and 17 other locations) |
| Trial ID | NCT03320304 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic or recurrent major depressive episodes that have not responded to multiple antidepressant treatments.
Not a fit: Patients who have not been diagnosed with treatment resistant depression or those who have not tried adequate antidepressant treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult to treat depression, potentially improving their quality of life.
How similar studies have performed: Previous studies on VNS Therapy have shown promising results in treating depression, indicating that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vienna and 17 other locations
- AKH Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria (Recruiting)
- KU Leuven — Leuven, Belgium (Recruiting)
- Sozialstiftung Bamberg - Klinikum am Bruderwald — Bamberg, Germany (Withdrawn)
- Universitätsklinikum Bonn — Bonn, Germany (Recruiting)
- Universitätsklinikum Köln — Cologne, Germany (Recruiting)
- LVR-Hospital Essen — Essen, Germany (Recruiting)
- Universitätsklinikum Frankfurt — Frankfurt, Germany (Recruiting)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (Completed)
- Universitätsmedizin Göttingen — Göttingen, Germany (Withdrawn)
- Medizinische Hochschule Hannover — Hanover, Germany (Withdrawn)
- Universitätsklinikum Jena — Jena, Germany (Completed)
- Universitätsklinik Leipzig — Leipzig, Germany (Recruiting)
- University Hospital Münster — Münster, Germany (Recruiting)
- Klinikum Wilhelmshaven — Wilhelmshaven, Germany (Active_not_recruiting)
- Glenfield hospital — Leicester, United Kingdom (Recruiting)
- King's College London — London, United Kingdom (Recruiting)
- Academic Psychiatry Wolfson Research Centre — Newcastle upon Tyne, United Kingdom (Recruiting)
- Mendip HTT / St Andrew's Ward — Wells, United Kingdom (Active_not_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.