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Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J. Todd Arnedt, University of Michigan
ClinicalTrials.gov Identifier:
NCT01545843
First received: January 12, 2012
Last updated: January 19, 2015
Last verified: January 2015
  Purpose

The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.


Condition Intervention Phase
Depression
Behavioral: Sleep scheduling
Drug: Fluoxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression-17 Item Minus Sleep Items [ Time Frame: Post-treatment (8 weeks) ] [ Designated as safety issue: No ]
    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:
  • Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: Post-treatment (8 weeks) ] [ Designated as safety issue: No ]
    Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.

  • Pittsburgh Sleep Quality Index [ Time Frame: Posttreatment (8 weeks) ] [ Designated as safety issue: No ]
    Self-report measure of sleep quality

  • Change in EEG Sleep Measures [ Time Frame: Baseline, 2 weeks, 8 weeks ] [ Designated as safety issue: No ]
    Measurement of EEG activity during sleep using polysomnography

  • Change in Neuropsychological Functioning [ Time Frame: Baseline, 2 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
    Change in multiple domains of neuropsychological functioning (e.g., memory, attention, executive functioning)


Enrollment: 68
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545843

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: J. Todd Arnedt, Ph.D. University of Michigan
  More Information

No publications provided

Responsible Party: J. Todd Arnedt, Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT01545843     History of Changes
Other Study ID Numbers: R01 MH077690
Study First Received: January 12, 2012
Results First Received: January 13, 2015
Last Updated: January 19, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
depression
sleep
treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Deprivation
Behavioral Symptoms
Dyssomnias
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders
Fluoxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015