Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- change of functional connectivity between pre/post rTMS
研究概览
简要总结
In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
详细描述
Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache.
We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS.
All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV major depressive episode
- •Failure of at least 3 different kind of antidepressant
排除标准
- •Organic brain disorder
- •Other diagnosis of DMS-IV except nicotine dependence
- •History of seizure disorder
结局指标
主要结局
change of functional connectivity between pre/post rTMS
时间窗: 14 days
次要结局
未报告次要终点