NCT00914680已完成3 期
Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Clinical Improvement (HAMD)
研究概览
简要总结
This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is diagnosed with a severe major depressive episode
- •Patient is in a chronic current MDE and/or has had a history of recurrent MDEs
- •Patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode
- •Patient has a score > 20 on the HAMD24
- •Patient is stable on current psychotropic medication for at least 4 weeks
- •Patient is > 25 and < 80 years
排除标准
- •Atypical Depression or psychotic depression (according to DSM IV)
- •Other relevant psychiatric axis I or axis II diseases
- •Relevant neurological diseases
- •Relevant cardiac or pulmonary diseases with enhances anesthesiological risk (ASA Score > 3)
- •Patient is currently enrolled in another investigational study not associated with the current study
- •Patient has a history of, or evidence of, significant brain malformation or significant head injury
研究组 & 干预措施
MST
Experimental
干预措施: magnetic seizure therapy (Procedure)
结局指标
主要结局
Clinical Improvement (HAMD)
时间窗: before, after treatment
次要结局
- Neurocognitive performance(before/after treatment)
研究者
Malek Bajbouj
Prof. Dr.
Charite University, Berlin, Germany
研究点 (2)
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