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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 : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
LivaNova

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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).
  • 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).
  • 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).
  • Assess all Adverse Events [ Time Frame: Implant to 12 Months ]
    All adverse events, with a focus on device or procedure-related serious adverse events.
  • WHO Disability Assessment Schedule (WHODAS) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
  • Health Outcome Scale (EQ-5D-L) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response [ Time Frame: 12 months post randomization ]
    Percentage of subjects with at least a 50% reduction from baseline in MADRS total score at 12 months from randomization
  • 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.
  • 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.
  • 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 (defined by reduction from baseline is < 40%).
  • Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission [ Time Frame: Baseline up to 12 Months ]
    Total amount of time (months) of subject in remission divided by the total months of study participation up to 12 months from randomization. Subjects discontinuing the study before the 12 months assessment will be considered as not in remission for each successive month after discontinuance.
  • 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).
  • 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).
  • 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).
  • Assess all Adverse Events [ Time Frame: Implant to 12 Months ]
    All adverse events, with a focus on device or procedure-related serious adverse events.
  • WHO Disability Assessment Schedule (WHODAS) Changes in scores over [ Time Frame: Baseline to 12 Months ]
  • Health Outcome Scale (EQ-5D-L) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
  • 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.
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE Device: Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Other Name: VNS
Study Arms  ICMJE
  • Active Comparator: Active
    Group will have VNS activated 2 weeks post implant.
    Intervention: Device: Vagus Nerve Stimulation (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.
    Intervention: Device: Vagus Nerve Stimulation (VNS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
6800
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
1000
Estimated Study Completion Date  ICMJE December 31, 2030
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Yates, BSN 281-228-7433 laura.yates@livanova.com
Contact: Jeff Way, BS 281-228-7394 jeffrey.way@livanova.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03887715
Other Study ID Numbers  ICMJE LND-300
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LivaNova
Study Sponsor  ICMJE LivaNova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles Conway, MD Washington University School of Medicine
PRS Account LivaNova
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP