Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
Study Overview
Brief Summary
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
No sleep deprivation
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
Intervention: Sleep scheduling (Behavioral)
No sleep deprivation
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Fluoxetine (Drug)
Outcomes
Primary Outcomes
Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
J. Todd Arnedt
Assistant Professor of Psychiatry
University of Michigan