RecruitingNot ApplicableNCT03887715
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Sponsor
LivaNova
Enrollment
6,800 participants
Start Date
Sep 26, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.
- The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.
- The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.
- Patients must maintain a stable medication regimen for at least four weeks before device implantation.
Exclusion Criteria7
- Current or lifetime history of psychotic features in any MDE;
- Current or lifetime history of schizophrenia or schizoaffective disorder;
- Current or lifetime history of any other psychotic disorder;
- Current or lifetime history of rapid cycling bipolar disorder;
- Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
- Current suicidal intent; or
- Treatment with another investigational device or investigational drugs.
Interventions
DEVICEVagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Locations(98)
View Full Details on ClinicalTrials.gov
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NCT03887715
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