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 |
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Recruitment Status :
Recruiting
First Posted : March 25, 2019
Last Update Posted : September 6, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment Resistant Depression | Device: Vagus Nerve Stimulation (VNS) | Not Applicable |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Active
Group will have VNS activated 2 weeks post implant.
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Device: Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Other Name: VNS |
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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.
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Device: Vagus Nerve Stimulation (VNS)
VNS is an implantable device that delivers stimulation to the vagal nerve.
Other Name: VNS |
- 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
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: Laura Yates, BSN | 281-228-7200 | laura.yates@livanova.com | |
| Contact: Jeff Way, BS | 281-228-7200 | jeffrey.way@livanova.com |
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| Principal Investigator: | Charles Conway, MD | Washington University School of Medicine |
| Responsible Party: | LivaNova |
| ClinicalTrials.gov Identifier: | NCT03887715 |
| Other Study ID Numbers: |
LND-300 |
| First Posted: | March 25, 2019 Key Record Dates |
| Last Update Posted: | September 6, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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VNS Depression TRD |
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Depression Depressive Disorder Depressive Disorder, Treatment-Resistant |
Behavioral Symptoms Mood Disorders Mental Disorders |