Clinical trial NCT01545843: Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Official title: Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: depression
sleep
treatment
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
timeFrame: Post-treatment (8 weeks)
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms (QIDS)
timeFrame: Post-treatment (8 weeks)
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 2 weeks and 8 weeks post-treatment
measure: Change in EEG Sleep Measures I: Total Sleep Time
timeFrame: Baseline, 2 weeks, 8 weeks
measure: Change in EEG Sleep Measures II (Sleep Efficiency)
timeFrame: Baseline, 2 weeks, 8 weeks
measure: Change in Neuropsychological Functioning: Memory
timeFrame: Baseline, 2 weeks, 8 weeks
measure: Change in Neurologic Functioning: Reaction Time
timeFrame: 0, 2, 8 weeks
measure: Neurological Function (Emotional Perception)
timeFrame: 0 weeks, 2 weeks, 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: J. Todd Arnedt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnedt JT, Swanson LM, Dopp RR, Bertram HS, Mooney AJ, Huntley ED, Hoffmann RF, Armitage R. Effects of Restricted Time in Bed on Antidepressant Treatment Response: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1218-e1225. doi: 10.4088/JCP.15m09879.