An Open-label, Follow-up Study on Remitted Patients With 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
- 42
- 试验地点
- 1
- 主要终点
- Relapse from depression
研究概览
简要总结
The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse.
详细描述
Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for depression treatment. The purpose of the present study is to determine whether tDCS is also an effective strategy for sustaining remission.
We will enroll patients who presented remission using tDCS from our previous study and offer them to tDCS every other week for three months, than once a month for another three months. We will address whether tDCS prevents relapse by assessing depression scores once a month, using a time-to-event analysis.
The importance of the present study is to determine whether tDCS is able to sustain remission during long-term follow-up of depressed patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 from previous studies (ID:USP-HU-001 and ID:USP-HU-002) who:
- •received tDCS and responded.
- •received tDCS + sertraline and responded.
- •received sertraline or placebo and did not respond, and thereafter received tDCS during the cross-over phase and responded.
排除标准
- •Patients from previous studies who:
- •received tDCS and did not respond.
- •received tDCS + sertraline and did not respond.
- •received sertraline or placebo and responded.
- •did not respond during the crossover phase.
- •do not wish to participate in the present study.
研究组 & 干预措施
Transcranial Direct Current 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.
The patient will receive tDCS every other week during the first three months, then once a month during the next three months.
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Relapse from depression
时间窗: Week 24
Same as above.
Relapse from depression
时间窗: Week 8
Same as above.
Relapse from depression
时间窗: Week 12
Same as above.
Relapse from depression
时间窗: Week 4
Once a month, we will address whether the patient has relapsed. Relapse criteria: * 2 consecutive MADRS scores \> 12 or * any MADRS scores \> 15 or * suicidal attempt or * severe suicidal ideation or * psychiatric hospitalization
Relapse from depression
时间窗: Week 16
Same as above.
Relapse from depression
时间窗: Week 20
Same as above.
次要结局
未报告次要终点
研究者
Andre Brunoni
MD
University of Sao Paulo