Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 21-item Hamilton Depression Rating Scale (HAM-D21)
研究概览
简要总结
We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain stimulation technique, is effective for treating major depression. We hypothesize that 4 weeks of DTMS will be associated with significant improvements in depressive and anxious symptoms without significant side effects.
详细描述
The aim of this pilot study is to assess, naturalistically, the effectiveness of deep transcranial magnetic stimulation (DTMS) in a sample of subjects with treatment-resistant depression. To do this, enrolled depressed outpatients will be assigned to receive 4 weeks of daily DTMS and will be evaluated at baseline and during week 5. We hypothesize that treatment with DTMS will be associated with significant clinical improvements in depressive and anxious symptoms, and will be well tolerated.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 1 but ≤ 5 adequate antidepressant trial(s) in the current episode
- •Baseline score ≥ 15 on the QIDS-C
- •Stable medication regimen (> 4 weeks)
排除标准
- •Psychotic features in the current episode
- •Lifetime history of psychotic disorders and/or bipolar I or II disorders
- •Substance or alcohol abuse/dependence in the past 6 months
- •Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- •Uncontrolled medical disease (e.g., cardiovascular, renal)
- •Pregnancy and/or lactation
- •Presence of a specific contraindication for DTMS (e.g., personal history of epilepsy, metallic head implant)
- •Hearing loss
- •Personal history of abnormal brain MRI findings
结局指标
主要结局
21-item Hamilton Depression Rating Scale (HAM-D21)
时间窗: week 5
Response to treatment is defined as a ≥ 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score ≤ 9.
次要结局
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)(week 5)
研究者
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute