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临床试验/NCT01189591
NCT01189591已完成不适用

Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Hamilton Depression Scale

研究概览

简要总结

Sleep deprivation can acutely reverse depressive symptoms in patients with major depression. Although underlying mechanisms of the antidepressant action in sleep deprivation are unclear, many of these observations can be explained by abnormal slow wave homeostasis. This study will test the prediction that selectively reducing slow waves during sleep (slow wave deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.

详细描述

see above

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
Single

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Among the inclusion criteria will be:
  • age range 18-35 years
  • right handedness
  • major depressive disorder according to DSM-IV (Diagnostic and Statical Manual-Revision 4) criteria (as determined by the Structured Clinical Interview for Diagnostic and Statical Manual-Revision 4), with Hamilton Rating Scale for *Depression scores of at least 18 on the first 17 items
  • no psychotropic medications for at least 4 weeks
  • no joint and muscular di
  • normal hearing
  • regular bedtimes and sleep duration, no time zone shifts in the last three weeks.

排除标准

  • Diabetes requiring insulin treatment
  • A serious heart disorder or subjects who have had a heart attack within the last 3 months
  • A diagnosis of cancer in the past 3 years and/or has active neoplastic disease
  • Clinically significant abnormalities on pre-study physical exam or physician evaluation
  • Subjects who meet DSM-IV (Diagnostic and Statical Manual-Revision 4) criteria for alcohol/drug abuse problems within the last six months or are currently using illegal drugs.
  • Female subjects of child-bearing potential who are pregnant or planning to become pregnant.
  • Women of child-bearing must be practicing a medically acceptable form of birth control.
  • Women of childbearing potential will be questioned about pregnancy status and form of birth control to be used at each visit.
  • Women who are unsure of their pregnancy status will be given a urine pregnancy test.
  • Subjects taking investigational medications
  • Subjects currently undergoing electroconvulsive therapy (ECT) or therapeutic transcranial magnetic stimulation (TMS).
  • Subjects who regularly perform night or late evening shift work (e.g. - "second" or "third" shifts) or have had travel with time zone shifts >3h in the last 3 weeks

研究组 & 干预措施

Sleep deprivation

Experimental

Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder

干预措施: Slow-wave deprivation (Device)

结局指标

主要结局

Hamilton Depression Scale

时间窗: 24 hours

次要结局

  • Inventory of Depressive Symptomology(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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