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

NCT03320304 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Vagal 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.

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Koen Demyttenaere, Prof. · KU Leuven

  • Allan Young, Prof. · King's College

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-14
Primary Completion
2029-12-01
Completion
2031-12-01
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • Germany
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320304 on ClinicalTrials.gov