NCT00770783已完成3 期
Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
University Hospital, Bonn2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical improvement (Hamilton Rating Scale for Depression)
研究概览
简要总结
The investigators intend to test in a single center, clinical pilot efficacy study the primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled pharmacotherapy is efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale (HAMD).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is diagnosed with a major depressive episode (MDE) according to DSM-IV Diagnosis Criteria derived from the SCID.
- •Patient has not had an acceptable clinical response due to failure (resistance) with at least two treatments from different treatment categories during the current MDE.
- •Patient has a score ≥ 20 on the 24-item Hamilton Rating Scale of Depression.
- •Patient is able to give his informed consent to participate in this study and he is able to fulfill the requirements of the study.
- •Patient is a male or nonpregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
- •Convulsive therapy clinically indicated
排除标准
- •Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnesia, or other cognitive disorders per DSM-IV.
- •Patient has had or has currently a diagnosis of non-affective psychotic disorder per DSM-IV.
- •Patient has had alcohol or substance dependence within the previous 12 months or abuse within the previous six months other than nicotine dependence or abuse.
- •Patient has a history or diagnosis of clinically relevant cardiac disease.
- •Patient has a history or diagnosis of clinically relevant injury or disease of the central nervous system.
- •Patient has magnetic material in the head.
- •Patient has implanted medical devices such as cardiac pacemaker, vagus nerve stimulator, medical pumps etc.
研究组 & 干预措施
Magnetic Seizure Therapy (MST)
Experimental
干预措施: Tonica MagPro MST (Device)
Electroconvulsive Therapy (ECT)
Active Comparator
干预措施: Thymatron (Device)
结局指标
主要结局
Clinical improvement (Hamilton Rating Scale for Depression)
时间窗: After each treatment and at followups up to 3 months after the treatment course
次要结局
- Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)(After each treatment and at followups up to 3 months after the treatment course)
研究者
Thomas E. Schlaepfer, MD
Professor of Psychiatry and Psychotherapy
University Hospital, Bonn
研究点 (2)
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