A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare antidepressant efficacy of right, left to sham
研究概览
简要总结
To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)
to determine if non-responders can become responders if treated on the other side of the hemisphere
(rTMS)
详细描述
Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Bipolar Depression
- •no physical health problems
排除标准
- •Metal in head/neck or skull
- •History of Epilepsy
- •Pregnancy
- •Pacemaker
研究组 & 干预措施
1, Phase l, True or Sham
this treatment will be True or Sham (placebo) on one side of the head, phase I
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
2, phase ll, Sham or True
This treatment will be Sham(placebo)or True on the other side of the head phase II.
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
结局指标
主要结局
To compare antidepressant efficacy of right, left to sham
时间窗: within 9 weeks
次要结局
- To determine if QEEG activity correlates with antidepressant response to rTMS(within 9 weeks)
- To determine if non-responders can become responders if treating the opposite hemisphere(within 9 weeks)