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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 (RECOVER)

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ClinicalTrials.gov Identifier: NCT03887715
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief 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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: Vagus Nerve Stimulation (VNS) Not Applicable

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization of active stimulation vs. no stimulation for 12 months post randomization.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Central Rater and sponsor are blinded in the RCT phase. Sites will need to have an unblinded programmer who is only programming the device and not collecting outcomes data.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Group will have VNS activated 2 weeks post implant.
Device: Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Other Name: VNS

Sham Comparator: Control
Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Device: Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Other Name: VNS




Primary Outcome Measures :
  1. Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response [ Time Frame: 12 months post randomization ]
    The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.

  2. Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response [ Time Frame: Baseline up to 12 Months ]
    Time from randomization to the first observed MADRS response.

  3. Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission [ Time Frame: Baseline up to 12 Months ]
    Time from randomization to the first observed MADRS remission.

  4. Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response [ Time Frame: Baseline up to 12 Months ]
    Duration of MADRS response, defined as the number of consecutive months from first observed MADRS response to the first assessment of MADRS response relapse.

  5. Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission [ Time Frame: Baseline up to 12 Months ]
    The rate of remission is defined as total number of months in remission divided by total months of expected study participation. Subjects discontinuing the study before the endpoint assessment will be considered as non-in-remission for each successive month after discontinuance

  6. Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response [ Time Frame: Baseline up to 12 Months ]
    Maximum duration of MADRS response, defined as the maximum number of consecutive months in response (only for subjects experiencing MADRS response).

  7. Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission [ Time Frame: Baseline up to 12 Months ]
    Duration of MADRS remission, defined as the number of consecutive months from first observed MADRS remission to the first assessment of MADRS remission relapse (defined score > 20).

  8. Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission [ Time Frame: Baseline up to 12 Months ]
    Maximum duration of MADRS remission, defined as the maximum number of consecutive months in remission (only for subjects experiencing MADRS remission).

  9. Assess all Adverse Events [ Time Frame: Implant to 12 Months ]
    All adverse events, with a focus on device or procedure-related serious adverse events.

  10. WHO Disability Assessment Schedule (WHODAS) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
  11. Health Outcome Scale (EQ-5D-L) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
  12. Clinical Global Impressions Scale - Improvement (CGI-I) Response [ Time Frame: 12 months post randomization ]
    A CGI-I score ≤ 2 at 12 months from randomization. Subjects discontinuing the study before the 12 months assessment will be considered as not in response for each successive month after discontinuance.

  13. Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality [ Time Frame: Implant to 12 Months ]
    Suicide attempts as measured by items #10 & #12 in S-STS scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887715


Contacts
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Contact: Laura Yates, BSN 281-228-7433 laura.yates@livanova.com
Contact: Jeff Way, BS 281-228-7394 jeffrey.way@livanova.com

Locations
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United States, California
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
Contact: Gustavo Alva, M.D.    714-277-4472    galva@atpcr.com   
United States, Florida
Medycal Research, Inc Recruiting
Brooksville, Florida, United States, 34609
Contact: Saniya Hassan    989-671-7119    drsaniyahassan@hotmail.com   
Clintex Research Group, Inc. Recruiting
Miami, Florida, United States, 33135
Contact: Melissa Valero    305-597-3929    Mvalero@clintexresearch.com   
Research Center Of Florida, Inc Recruiting
Miami, Florida, United States, 33135
Contact: Damian Beltran-Garces    305-603-8844    dgarces@doctor.com   
Galiz Research LLC Recruiting
Miami, Florida, United States, 33166
Contact: diana aguirre    305-603-8844    dsamed@galizresearch.com   
Advanced Mental Health Care Inc. Recruiting
Royal Palm Beach, Florida, United States, 33411
Contact: Aron Tendler, M.D.    561-386-1600    aron.tendler@gmail.com   
United States, Georgia
IACT Health Recruiting
Grayson, Georgia, United States, 30017
Contact: Muhammed Ahmed, M.D.    678-798-2153    mahmed@iacthealth.com   
Psych Atlanta Recruiting
Marietta, Georgia, United States, 30060
Contact: Michael Banov, M.D.    770-422-2846    banov@mindspring.com   
United States, Illinois
Psychiatric Medicine Associates, LLC Recruiting
Skokie, Illinois, United States, 60076
Contact: Amanda White    847-679-8000 ext 12    awhite.pma@gmail.com   
United States, Maryland
Clinical Insights Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Norhan Adler    410-768-9072    ibrahim@clinicalinsights.com   
United States, Michigan
Michigan Clinical Research Institute PC Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Mohammad Al-Matarneh, M.D.    734-834-8954    m.matarneh78@gmail.com   
United States, Missouri
PsychCare Consultants Research Recruiting
Saint Louis, Missouri, United States, 63128
Contact: Anita Broeker    314-849-1853 ext 203    anita.broeker@pccresearch.org   
United States, Nebraska
Alivation Research, LLC Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Walter Duffy, M.D.    402-817-2235    drduffy@alivation.com   
United States, New York
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact: Mark DiBuono, M.D.    718-317-5522 ext 302    dibuono@rbany.com   
United States, Oklahoma
Rivus Wellness & Research Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Marvin Peyton, MD    405-753-4994    drpeyton@rivusinstitute.com   
United States, Vermont
Neuropsychiatric Associates, Plc Recruiting
Woodstock, Vermont, United States, 05091
Contact: Susan Smiga    802-457-4904    ssmiga@woodstockresearch.org   
Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Charles Conway, MD Washington University School of Medicine

Additional Information:
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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT03887715     History of Changes
Other Study ID Numbers: LND-300
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by LivaNova:
VNS
Depression
TRD
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders