Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- HAMD-17
研究概览
简要总结
Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials
详细描述
This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants)
- •age 18-65; Male or female
- •the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes
- •HAMD-17 score> 17 was at baseline
排除标准
- •pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures
- •a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms
- •patients currently at serious risk of suicide
- •prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine
- •patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy)
- •accept other clinical trials
- •patients requiring systemic mri after implantation
结局指标
主要结局
HAMD-17
时间窗: 6 months
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline
次要结局
- HAMD-17(12months)
- MADRS(12months)
- IDS-SR(12months)
- CGI(12months)
- PSQI(12months)