NCT02562677Unknown1 期
Effect of TNS for Major Depressive Disorder in the Elderly: a Phase II Randomized Controlled Trial
Santa Casa Medical School0 个研究点目标入组 10 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 主要终点
- Hamilton Depressive Rating Scale version 17 items (HDRS-17)
研究概览
简要总结
This is a phase II, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.
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
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 65 and 99 years
- •patients with a diagnosis of depression according to the SCID
- •score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
- •agreement to participate in the study as recommended in the IC.
排除标准
- •patients with psychiatric indication for hospitalization
- •patients with psychiatric comorbidity
- •patients with a diagnosis of personality disorder
- •presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
结局指标
主要结局
Hamilton Depressive Rating Scale version 17 items (HDRS-17)
时间窗: Change from baseline in depressive symptoms at 2 weeks ]
This clinical trial has as primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in elderly patients with moderate / severe depressive episode
次要结局
未报告次要终点
研究者
Pedro Shiozawa
Coordinator - Interdisciplinary Center for Clinical Neuromodulation
Santa Casa Medical School
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