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Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

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ClinicalTrials.gov Identifier: NCT01545843
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : January 30, 2015
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
J. Todd Arnedt, University of Michigan

Study Description
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Brief Summary:
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Sleep scheduling Drug: Fluoxetine Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Study Start Date : March 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: No sleep deprivation
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
 Behavioral: Sleep scheduling
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime

Drug: Fluoxetine
20-40 mg fluoxetine daily for 8 weeks
Other Name: Prozac
Experimental: 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.
 Behavioral: Sleep scheduling
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime

Drug: Fluoxetine
20-40 mg fluoxetine daily for 8 weeks
Other Name: Prozac
Experimental: 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.
 Behavioral: Sleep scheduling
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime

Drug: Fluoxetine
20-40 mg fluoxetine daily for 8 weeks
Other Name: Prozac


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: Post-treatment (8 weeks) ]
    Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.

  2. Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 2 weeks and 8 weeks post-treatment ]
    Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.

  3. Change in EEG Sleep Measures I: Total Sleep Time [ Time Frame: Baseline, 2 weeks, 8 weeks ]
    Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.

  4. Change in EEG Sleep Measures II (Sleep Efficiency) [ Time Frame: Baseline, 2 weeks, 8 weeks ]
    Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100]

  5. Change in Neuropsychological Functioning: Memory [ Time Frame: Baseline, 2 weeks, 8 weeks ]
    Change in different aspects of thinking (e.g., memory, attention, executive functioning)

  6. Change in Neurologic Functioning: Reaction Time [ Time Frame: 0, 2, 8 weeks ]
    Reaction Time is measured using a modified Go/No-go test of inhibitory control

  7. Neurological Function (Emotional Perception) [ Time Frame: 0 weeks, 2 weeks, 8 weeks ]
    Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545843


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: J. Todd Arnedt, Ph.D. University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: J. Todd Arnedt, Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT01545843    
Other Study ID Numbers: R01MH077690 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2012    Key Record Dates
Results First Posted: January 30, 2015
Last Update Posted: December 8, 2017
Last Verified: November 2017
Keywords provided by J. Todd Arnedt, University of Michigan:
depression
sleep
treatment
Additional relevant MeSH terms:
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Sleep Deprivation
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Fluoxetine
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors