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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- LivaNova
- 入组人数
- 6,800
- 试验地点
- 193
- 主要终点
- Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active
Group will have VNS activated 2 weeks post implant.
干预措施: Vagus Nerve Stimulation (VNS) (Device)
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.
干预措施: Vagus Nerve Stimulation (VNS) (Device)
结局指标
主要结局
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission
时间窗: 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 Remission
时间窗: 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).
Health Outcome Scale (EQ-5D-L) Changes in scores over time
时间窗: Baseline to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response
时间窗: Baseline up to 12 Months
Time from randomization to the first observed MADRS response.
Assess all Adverse Events
时间窗: Implant to 12 Months
All adverse events, with a focus on device or procedure-related serious adverse events.
Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality
时间窗: Implant to 12 Months
Suicide attempts as measured by items #10 \& #12 in S-STS scale
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response
时间窗: 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.
WHO Disability Assessment Schedule (WHODAS) Changes in scores over time
时间窗: Baseline to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response
时间窗: 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 Remission
时间窗: Baseline up to 12 Months
Time from randomization to the first observed MADRS remission.
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response
时间窗: 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
时间窗: 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).
Clinical Global Impressions Scale - Improvement (CGI-I) Response
时间窗: 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.
次要结局
未报告次要终点