ACTRN12611000054910已完成不适用
A randomised controlled trial of Magnetic Seizure Therapy for the treatment of Major Depressive Disorder
Professor Paul Fitzgerald0 个研究点目标入组 40 人开始时间: 2011年1月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Age 18-75 and a DSM-IV diagnosis of a major depressive episode (uni or bipolar depression) (diagnosis made using the standard structured clinical interview for the DSM-IV (SCID I) instrument).
- •Patients with psychotic symptoms as part of their mood episode will not be excluded if able to give informed consent.
- •Are referred for or are otherwise suitable for a course of ECT as determined by their treating psychiatrist
- •Hamilton Depression Rating Scale (17 item version) score of > 18 (moderate – severe depression): note – some authors have defined moderate depression on the 17 item HAMD as >14. We have selected a higher cut off to ensure all patients clearly have depression of substantial clinical severity. It is likely that most patients will have scores in the severe or extremely severe ranges.
- •Score greater than 23 on the Mini Mental State Examination
- •Have treatment resistant depression at Stage II of the Thase and Rush classification. This requires failure to respond to adequate courses of several courses of antidepressants.
- •Demonstrated capacity to give informed consent
排除标准
- •Patients who are too unwell to undergo general anesthetic.
- •Patients with metallic implants in the head, cardiac pacemakers, cochlear implants or other implanted electronic devices
- •Treatment with ECT in the last three months
- •Presence of another DSM-IV Axis I psychiatric disorder (on SCID I) other than bipolar disorder
- •Presence of substance abuse or dependence during the last six months (on SCID I)
- •Current pregnancy
- •Past history of stroke, neurodegenerative disorder or other major neurological illness
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