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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2030
  • participants needed
    6800
  • sponsor
    LivaNova
Updated on 11 December 2020
Investigator
Brittany Troen, MA
Primary Contact
Sheppard Pratt Health System, Inc. (9.3 mi away) Contact
+49 other location
depressive disorder
depressive symptoms
depressive episode

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.

Description

A prospective, multi-center, randomized, controlled, blinded trial of subjects implanted with VNS Therapy. Active treatment and no stimulation control are randomized, at least two weeks after implantation and observed for 12-months.

After completing the 12 month endpoint in the RCT portion of the study, all RECOVER subjects will transition into the prospective, open-label, longitudinal portion of the study. Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint.

After completion of enrollment in the RCT portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. These subjects will participate in the study for approximately 5 years.

The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development (CED) decision entitled "Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2).

Details
Treatment Vagus Nerve Stimulation (VNS)
Clinical Study IdentifierNCT03887715
SponsorLivaNova
Last Modified on11 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Treatment Resistant Depression?
Do you have any of these conditions: Do you have Treatment Resistant Depression??
Do you have any of these conditions: Do you have Treatment Resistant Depression??
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
-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
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