A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Recruiting now
Conditions studied: Treatment Resistant Depression
In brief
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.
Key facts
- Study ID
- NCT03320304
- Run by
- LivaNova
- People needed
- 500
- Starts
- 2017-12-14
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
Where it is running
- Universitätsklinik Leipzig — Leipzig, Germany (enrolling)
- University Hospital Münster — Münster, Germany (enrolling)
- Universitätsklinikum Frankfurt — Frankfurt, Germany (enrolling)
- Glenfield hospital — Leicester, United Kingdom (enrolling)
- King's College London — London, United Kingdom (enrolling)
- Academic Psychiatry Wolfson Research Centre — Newcastle upon Tyne, United Kingdom (enrolling)
- AKH Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria (enrolling)
- KU Leuven — Leuven, Belgium (enrolling)
- Universitätsklinikum Bonn — Bonn, Germany (enrolling)
- Universitätsklinikum Köln — Cologne, Germany (enrolling)
- LVR-Hospital Essen — Essen, Germany (enrolling)
- Mendip HTT / St Andrew's Ward — Wells, United Kingdom
- Sozialstiftung Bamberg - Klinikum am Bruderwald — Bamberg, Germany
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
- Universitätsmedizin Göttingen — Göttingen, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Universitätsklinikum Jena — Jena, Germany
- Klinikum Wilhelmshaven — Wilhelmshaven, Germany
Full record on ClinicalTrials.gov
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