The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version
研究概览
简要总结
This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria include:
- •Subjects must be English speaking
- •Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
- •Subjects must be between : 18 to 75
- •Non-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.
排除标准
- •Exclusion criteria include:
- •Suicidality, or psychosis
- •Unstable medical conditions
- •Epilepsy, serious head injury, or other significant neurological disorders
- •Dementia, mental retardation (moderate or severe), coma
- •Prior exposure to radiation which might cause the subject to exceed standard guidelines
- •Substance abuse or alcoholism in the past six months
- •Unreliability or inability to adhere to the requirements of the study
- •Irregular sleep-wake schedules (nightshift, jet lag)
- •Use of CNS medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep EEG)
- •Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
- •Donation or loss of blood (>400 ml) within the past month
- •Current or very recent intercurrent illnesses, painful conditions or other disorders, which in the judgement of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for the subject.
- •Hamilton Rating Scale of Depression (HRSD-17 items)<17 unless subject is a normal control subject.
- •Pregnancy or breast feeding
- •Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body.
- •Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
- •Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
- •Subjects with diagnosis of eating disorder/bulimia
研究组 & 干预措施
Chronobiological augmentation
chronobiological augmentation group
干预措施: chronobiological augmentation (Other)
Medication only
medication only group
干预措施: sertraline, lithium (Drug)
MDD Mechanism
干预措施: one night of sleep deprivation and two FDG PET scans (Radiation)
结局指标
主要结局
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version
时间窗: within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy
Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.
次要结局
未报告次要终点
研究者
Joseph Wu
Professor of Psychiatry & Human Behavior
University of California, Irvine