An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment Response
研究概览
简要总结
The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS) in patients of the investigators previous study who received either placebo or sertraline and have not responded.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 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 from a previous study (ID:USP-HU-001) who:
- •received sertraline and did not respond.
- •received placebo and did not respond.
排除标准
- •Patients from a previous study who:
- •received active tDCS.
- •responded.
研究组 & 干预措施
active stimulation
In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
干预措施: transcranial direct current stimulation (Procedure)
结局指标
主要结局
Treatment Response
时间窗: Week 1
Response is defined as MADRS \<=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).
Treatment response
时间窗: Week 2
Response defined as above.
次要结局
未报告次要终点
研究者
Andre Brunoni
P.I., Research Associate
University of Sao Paulo