Actively Recruiting
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Led by LivaNova · Updated on 2026-01-26
500
Participants Needed
18
Research Sites
728 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, confirmed using the MINI.
- Provide written informed consent and authorization as required.
- Currently receiving at least one antidepressant treatment or mood stabilizing treatment for bipolar disorder.
- Able and willing to comply with outpatient clinic visits and complete all evaluations specified in the study protocol.
You will not qualify if you...
- Patients with mental retardation.
- Current severe or significant substance or alcohol abuse.
- Diagnosis of one or more schizophrenia-spectrum or other psychotic disorders.
- Diagnosis of borderline or severe personality disorder that would significantly interfere with study participation, as determined by clinical judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
AKH Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, 1090
Actively Recruiting
2
KU Leuven
Leuven, Belgium
Actively Recruiting
3
Sozialstiftung Bamberg - Klinikum am Bruderwald
Bamberg, Germany
Withdrawn
4
Universitätsklinikum Bonn
Bonn, Germany
Actively Recruiting
5
Universitätsklinikum Köln
Cologne, Germany
Actively Recruiting
6
LVR-Hospital Essen
Essen, Germany, 45147
Actively Recruiting
7
Universitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
8
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Completed
9
Universitätsmedizin Göttingen
Göttingen, Germany
Withdrawn
10
Medizinische Hochschule Hannover
Hanover, Germany
Withdrawn
11
Universitätsklinikum Jena
Jena, Germany
Completed
12
Universitätsklinik Leipzig
Leipzig, Germany, 04103
Actively Recruiting
13
University Hospital Münster
Münster, Germany
Actively Recruiting
14
Klinikum Wilhelmshaven
Wilhelmshaven, Germany
Active, Not Recruiting
15
Glenfield hospital
Leicester, United Kingdom, LE3 9EJ
Actively Recruiting
16
King's College London
London, United Kingdom
Actively Recruiting
17
Academic Psychiatry Wolfson Research Centre
Newcastle upon Tyne, United Kingdom
Actively Recruiting
18
Mendip HTT / St Andrew's Ward
Wells, United Kingdom, BA5 1TH
Active, Not Recruiting
Research Team
F
Funda Basdar
CONTACT
G
Gaia Giannicola
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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