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 (RECOVER)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2030
  • participants needed
    6800
  • sponsor
    LivaNova
Updated on 23 July 2022
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
Condition Treatment Resistant Depression
Treatment Vagus Nerve Stimulation (VNS)
Clinical Study IdentifierNCT03887715
SponsorLivaNova
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

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 secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder
Current or lifetime history of rapid cycling bipolar disorder
Current suicidal intent; or
Treatment with another investigational device or investigational drugs
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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