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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

Recruiting

This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD. The objective of this study is to determine whether active VNS Therapy treatment improves health outcomes for Treatment Resistant Depression (TRD) subjects compared to a no stimulation control in depressive symptoms. This prospective, multicenter trial is composed of two parts: - The RCT and Follow-up (RCT) is a randomized, controlled, blinded trial to determine if active VNS Therapy treatment compared to a no stimulation control improves depressive symptoms. - The Longitudinal Registry (LR) is an observational, open label, single arm study aimed at assessing the long-term effectiveness and safety of VNS Treatment.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:
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 Criteria:
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.

Device: Vagus Nerve Stimulation (VNS)

Treatment Resistant Depression

VNS, Depression, TRD

Interventional Psychiatry Lab Study - ipl@umn.edu
Ziad Nahas
N/A
STUDY00009412
NCT03887715
See this study on ClinicalTrials.gov

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