NCT02562703Unknown1 期
Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial
Santa Casa Medical School0 个研究点目标入组 40 人开始时间: 2015年11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
- 40
- 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, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 18 and 69 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 tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in 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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