RecruitingTreatment Resistant Depression

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

Eligible age

18+ yrs

Accepts

All genders

Locations

32 states

Healthy volunteers

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About this study

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.

Sponsor: LivaNova

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.