A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
NCT ID: NCT03320304
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2017-12-14
2031-12-01
Brief Summary
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Detailed Description
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The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).
A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study.
Enrollment will take 8 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant.
Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. The study may stop when the last subject has reached the 36 months follow-up.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vagal Nerve Simulation (VNS) Therapy
The aim of this study is to include patients with difficult to treat depression from a global "real world" (standard of care) population who are referred for treatment with VNS Therapy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Koen Demyttenaere, Prof.
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Allan Young, Prof.
Role: PRINCIPAL_INVESTIGATOR
King's College
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Christoph Kraus, Dr.
Role: primary
Koen Demyttenaere, Prof.
Role: primary
Margaretha Klein, MD
Role: primary
Fritz-Georg Lehnhardt
Role: primary
Norbert Scherbaum, Prof.
Role: primary
Christine Reif-Leonhard
Role: primary
Maria Strauss, MD
Role: primary
Bernhard Baune, Prof.
Role: primary
Ganesh Kunjithapatham, Dr.
Role: primary
Allan Young, Prof.
Role: primary
Hamish McAllister-Williams, Prof.
Role: primary
References
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Kavakbasi E, Kraus C, Reif-Leonhard C, Blackwell JM, Dibue M, Treiber M, Achten S, Baune BT. Titration of vagus nerve stimulation for difficult-to-treat depression and onset of response: Early insights from the RESTORE-LIFE study. J Affect Disord. 2025 Jun 1;378:39-46. doi: 10.1016/j.jad.2025.02.047. Epub 2025 Feb 26.
Kavakbasi E, Baune BT. Combination of Acute and Maintenance Esketamine Treatment With Adjunctive Long-Term Vagus Nerve Stimulation in Difficult-to-Treat Depression. Neuromodulation. 2024 Jun;27(4):766-773. doi: 10.1016/j.neurom.2023.12.004. Epub 2024 Feb 10.
Kavakbasi E, Rosemann K, Yilmaz M, Vasileiadou A, Falcone V, Baune BT. Vagus Nerve Stimulation Combined With Alternating Synchronized and Nonsynchronized Intermittent Theta Burst Stimulation in Difficult-to-Treat Depression. J ECT. 2024 Mar 1;40(1):62-63. doi: 10.1097/YCT.0000000000000964. Epub 2023 Dec 28. No abstract available.
Young AH, Juruena MF, De Zwaef R, Demyttenaere K. Vagus 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. BMC Psychiatry. 2020 Sep 29;20(1):471. doi: 10.1186/s12888-020-02869-6.
Other Identifiers
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LNN800
Identifier Type: -
Identifier Source: org_study_id
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