RecruitingNCT03320304

A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With 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.


Sponsor

LivaNova

Enrollment

500 participants

Start Date

Dec 14, 2017

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how well vagus nerve stimulation (VNS) — a small device implanted under the skin that sends mild electrical pulses to the brain — works for people with long-lasting or recurring severe depression that has not improved with multiple antidepressant treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with chronic (more than 2 years) or recurring major depression - You have tried multiple antidepressant treatments without sufficient improvement - You are willing to give written consent **You may NOT be eligible if...** - Your depression is secondary to another medical condition - You have had a previous VNS device implanted - You have conditions that make surgery or the device unsafe (e.g., certain heart conditions) - You have bipolar disorder or psychosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVagal Nerve Simulation (VNS) Therapy

A VNS Therapy System used for vagus nerve stimulation and consisting of an implantable VNS Therapy generator, lead, and external programming system.


Locations(18)

AKH Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

KU Leuven

Leuven, Belgium

Sozialstiftung Bamberg - Klinikum am Bruderwald

Bamberg, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Köln

Cologne, Germany

LVR-Hospital Essen

Essen, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsklinik Leipzig

Leipzig, Germany

University Hospital Münster

Münster, Germany

Klinikum Wilhelmshaven

Wilhelmshaven, Germany

Glenfield hospital

Leicester, United Kingdom

King's College London

London, United Kingdom

Academic Psychiatry Wolfson Research Centre

Newcastle upon Tyne, United Kingdom

Mendip HTT / St Andrew's Ward

Wells, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03320304


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