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临床试验/NCT03169543
NCT03169543已完成不适用

Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Change in HAMD-NOW scores

研究概览

简要总结

From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and SD. Here we propose to study a group of N=48 antidepressant-free male and female patients with current depression symptom and N=12 healthy controls with no history of mood disorders before and after SD to provide mechanistic insight into the neural substrates underlying the antidepressant effects of SD. We hypothesize that SD-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total SD, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.

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
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Current depression as assessed on the HDRS-17 (for depressed group only)
  • Body mass index within 15% of normal
  • Stable, normally-timed sleep-wake cycle defined by: a. Habitual nocturnal sleep duration between 6h and 9h. b. Habitual morning awakening between 0600h and 0800h.
  • Able to comprehend English, as all questionnaires are in this language
  • Ability to provide informed consent

排除标准

  • Shift work, transmeridian travel or irregular sleep/wake routine in past 60 days
  • A sleep disorder other than insomnia
  • History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders
  • No history of depression for the control group.
  • Alcohol or drug abuse in the past year
  • A current smoker.
  • Any acute or chronic, debilitating medical conditions, epilepsy, or thyroid disease.
  • Metallic implants, pacemakers or tattoos, or history of working in metal workshops.
  • Claustrophobic, or intolerant of the scanner environment.
  • For women, pregnancy will exclude participation.

结局指标

主要结局

Change in HAMD-NOW scores

时间窗: Each morning for 4 days

Total score on a modified Hamilton Depression Inventory that assesses mood symptoms in the moment.

次要结局

  • Change in neuroimaging(Each morning for 3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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