Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
研究概览
简要总结
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
详细描述
Depression is common and associated with social and economic costs. Although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms.
New treatments that accelerate response to antidepressants are important to reduce the burden of depression. The objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response.
Participants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.
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
- Single (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
- •Between 18 and 65 years old
- •Current major depressive episode
- •Habitual TIB of 7 to < 10 hours
- •No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)
- •Score of at least 18 on the Hamilton Rating Scale of Depression
排除标准
- •Alcohol or substance abuse/dependence in past 6 months
- •Current posttraumatic stress disorder or bulimia nervosa (past 6 months)
- •Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa
- •Trials of fluoxetine in the past 6 months
- •Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of > 5 minutes; history of seizures
- •Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder
- •Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)
- •Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).
- •Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.
- •Known allergy, hypersensitivity or contraindication to study medication
- •Females: pregnant or nursing
研究组 & 干预措施
No sleep deprivation
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
干预措施: Sleep scheduling (Behavioral)
No sleep deprivation
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
干预措施: Fluoxetine (Drug)
Late bedtime sleep deprivation
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
干预措施: Sleep scheduling (Behavioral)
Late bedtime sleep deprivation
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
干预措施: Fluoxetine (Drug)
Early risetime sleep deprivation
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.
干预措施: Sleep scheduling (Behavioral)
Early risetime sleep deprivation
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
时间窗: Post-treatment (8 weeks)
Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.
次要结局
- Quick Inventory of Depressive Symptoms (QIDS)(Post-treatment (8 weeks))
- Change in EEG Sleep Measures II (Sleep Efficiency)(Baseline, 2 weeks, 8 weeks)
- Change in Neurologic Functioning: Reaction Time(0, 2, 8 weeks)
- Neurological Function (Emotional Perception)(0 weeks, 2 weeks, 8 weeks)
- Pittsburgh Sleep Quality Index(Baseline, 2 weeks and 8 weeks post-treatment)
- Change in Neuropsychological Functioning: Memory(Baseline, 2 weeks, 8 weeks)
- Change in EEG Sleep Measures I: Total Sleep Time(Baseline, 2 weeks, 8 weeks)
研究者
J. Todd Arnedt
Assistant Professor of Psychiatry
University of Michigan