A Global PRospective, Multi-cEnter, ObServational Post-markeT Study tO Assess shoRt, Mid and Long-term Effectiveness and Efficiency of VNS Therapy® as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- LivaNova
- 入组人数
- 500
- 试验地点
- 26
- 主要终点
- The primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant.
研究概览
简要总结
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.
详细描述
The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management.
The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).
A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study.
Enrollment will take 11 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant.
Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. The study may stop when the last subject has reached the 36 months follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Be at least 18 years of age.
- •Have a documented primary diagnosis of chronic (>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.
- •Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).
- •Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).
- •Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)
排除标准
- •There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
研究组 & 干预措施
Vagal Nerve Simulation (VNS) Therapy
The aim of this study is to include patients with difficult to treat depression from a global "real world" (standard of care) population who are referred for treatment with VNS Therapy.
干预措施: Vagal Nerve Simulation (VNS) Therapy (Device)
结局指标
主要结局
The primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant.
时间窗: 12 months
MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression. A 'Responder' is a subject that achieved ≥ 50% reduction from baseline in MADRS total score at the M12 assessment. A 'Non-Responder' is any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at the M12 assessment. No formal hypothesis testing is presented; all the proposed statistical tests are descriptive in nature. The Primary endpoint analysis as defined above will be done only on patients that are enrolled while in a major depressive episode (MDE); the cut off point for current MDE at time of implant will be a MADRS score of 20. For the patients with a MADRS score below 20 at time of enrollment, only the continuous change in MADRS can be described (as the MADRS can only worsen or stay the same).
次要结局
- Changes in suicidality as measured by item #10 of MADRS.(through study completion, an average of 4 years)
- Changes in suicidality as measured by item #12 of QIDS-SR.(through study completion, an average of 4 years)
- Duration of response(through study completion, an average of 4 years)
- Cumulative response(through study completion, an average of 4 years)
- Cumulative remission(through study completion, an average of 4 years)
- Changes in depression score As measured by the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR).(through study completion, an average of 4 years)
- Change in MADRS(through study completion, an average of 4 years)
- Changes in mania score as measured by the Altman Self-Rating Mania Scale (ASRM)*.(through study completion, an average of 4 years)
- Changes in Quality of Life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)(through study completion, an average of 4 years)
- Changes in patient function as measured by the Work Productivity and Activity Impairment Scale (WPAI)(through study completion, an average of 4 years)
- Changes in Quality of Life and patient function as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(through study completion, an average of 4 years)
- Changes in adjunctive antidepressant pharmacological treatment(through study completion, an average of 4 years)
- Changes in adjunctive antidepressant non-pharmacological treatment(through study completion, an average of 4 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](through study completion, an average of 4 years)
- Changes in cognition(through study completion, an average of 4 years)
- Changes in anxiety as measured by the Generalized Anxiety Disorder Assessment (GAD 7)*.(through study completion, an average of 4 years)