Titration of vagus nerve stimulation for difficult-to-treat depression and onset of response: Early insights from the RESTORE-LIFE study.
Erhan Kavakbasi, Christoph Kraus, Christine Reif-Leonhard...
https://pubmed.ncbi.nlm.nih.gov/40021060Actively Recruiting
Age: 18Years +
All Genders
ID03320304
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
Led by LivaNova · Updated on 2026-01-26
500
Participants Needed
18
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the short, mid, and long-term clinical outcomes of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for patients with difficult to treat depression, including those with treatment resistant depression. The study focuses on adults diagnosed with unipolar or bipolar disorder who have chronic or recurrent depression that has not responded well to standard psychiatric treatments. Depression diagnosis and comorbid conditions will be confirmed using the Mini International Neuropsychiatric Interview (MINI). Participants will receive a VNS Therapy System, which includes an implantable generator, lead, and external programming system for vagus nerve stimulation. The study will enroll at least 500 patients across up to 80 sites worldwide. Each participant will have a baseline visit 1 to 6 weeks before device implantation, followed by regular follow-ups for a minimum of 36 months and up to 60 months after implantation. During the study, participants will attend outpatient clinic visits to complete various evaluations and assessments. Researchers will measure depression symptoms using the Montgomery Åsberg Depression Rating Scale (MADRS) and other tools over an average of 4 years. They will also track quality of life, patient function, suicidality, cognition, anxiety, and changes in antidepressant treatments. Safety and tolerability will be monitored through the incidence of treatment-emergent adverse events.
CONDITIONS
Brief Title
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Who Can Participate
Age: 18Years +
All Genders
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 not adequately responding to an adequate number of antidepressant treatments.
- Diagnosis must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- Provide written informed consent approved by Ethics Committee or Institutional Review Board.
- Currently receiving at least one antidepressant treatment or mood stabilizing treatment for bipolar patients.
- Able and willing to comply with outpatient clinic visit frequency and complete all study evaluations.
You will not qualify if you...
- Patients with mental retardation.
- Patients with 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 significantly interferes with study participation, as determined by clinical judgment.
- No other exclusion criteria beyond the local applicable VNS Therapy Physician's Manual.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 to 6 weeks before implant
Participants undergo diagnostic evaluation including confirmation of depression diagnosis using the Mini International Neuropsychiatric Interview (MINI).
1 baseline visit (in-person)
Implementation
Duration - Day of implant
Participants receive implantation of the VNS Therapy System as adjunctive treatment for difficult to treat depression.
1 implant visit (in-person)
Long-term Monitoring
Duration - Minimum 36 months to maximum 60 months
Participants are followed for effectiveness, safety, and quality of life outcomes after VNS Therapy implantation in a real-world setting.
Regular follow-up visits over 3 to 5 years
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
Loading map...
Research Team
F
Funda Basdar
G
Gaia Giannicola
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Combination of Acute and Maintenance Esketamine Treatment With Adjunctive Long-Term Vagus Nerve Stimulation in Difficult-to-Treat Depression.
Erhan Kavakbasi, Bernhard T Baune
https://pubmed.ncbi.nlm.nih.gov/38340111Vagus Nerve Stimulation Combined With Alternating Synchronized and Nonsynchronized Intermittent Theta Burst Stimulation in Difficult-to-Treat Depression.
Erhan Kavakbasi, Kevin Rosemann, Mert Yilmaz...
https://pubmed.ncbi.nlm.nih.gov/38194603Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study.
Allan H Young, Mario F Juruena, Renske De Zwaef...
https://pubmed.ncbi.nlm.nih.gov/32993573