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 5 August 2021
Investigator
Tina Marzullo
Primary Contact
AMR- Baber Research, Inc. (7.6 mi away) Contact
+70 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
Condition Treatment Resistant Depression
Treatment Vagus Nerve Stimulation (VNS)
Clinical Study IdentifierNCT03887715
SponsorLivaNova
Last Modified on5 August 2021

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
-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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note