NCT02778256招募中不适用
Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
Vest Brain,Centro de Estudios Neurovestibulares2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Remission rates of depression.
研究概览
简要总结
Vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. This study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type I and II patients. After randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 previous weeks with depression symptoms.
- •bipolar disorder type I actual depressive phase
- •bipolar disorder type II actual depressive phase
- •Montgomery Asberg depression scale(MADRS) score equal or more than 20
- •stable psychiatric medication during 2 weeks previous the recruitment
排除标准
- •pregnancy
- •neurologic disorder
- •drugs or alcohol abuse during the 2 weeks previous the recruitment
- •presence of maniac state(Young mania scale score more than 7)
结局指标
主要结局
Remission rates of depression.
时间窗: 90 days
次要结局
- Percentage of vestibular change.(90 days)
- Response rates of depression(90 days)
研究者
研究点 (2)
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