NCT01431001已完成不适用
Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
Cervel Neurotech, Inc.8 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Remission from depression
研究概览
简要总结
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive disorder (MDD)
- •Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.
- •Will not become pregnant during study.
排除标准
- •Seizure disorder.
- •History of brain injury or active CNS disease.
- •Metal implants on or in brain, spinal cord, ear, eye or heart.
- •Current use of proconvulsant medications (e.g., bupropion).
- •Other significant psychiatric disorder.
- •Substance use disorder (not including caffeine or nicotine).
- •7 or more failed treatment attempts for depression in one's lifetime.
- •Have failed to clinically remit to an adequate trial of ECT or TMS.
结局指标
主要结局
Remission from depression
时间窗: baseline through 4 weeks post
Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post
次要结局
- Safety and tolerability of rTMS(baseline through 4 weeks post)
研究者
研究点 (8)
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