Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression - Full Text View

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:

MedlinePlus related topics: Depression

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Change in Clinician-Rated Depression Symptoms: Hamilton Rating Scale for Depression-17 item [ Time Frame: Baseline, 2 weeks, 8 weeks ] [ Designated as safety issue: No ]
Clinician-rated measure of depressive symptoms

Secondary Outcome Measures:

Change in Self-rated Depression Symptoms: Quick Inventory of Depressive Symptoms [ Time Frame: Baseline, 2 weeks, 8 weeks ] [ Designated as safety issue: No ]
Patient-reported depressive symptoms
Change in Sleep Quality: Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 2 weeks, 8 weeks ] [ Designated as safety issue: No ]
Self-report 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)

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: No sleep deprivation 8 hours time in bed plus medication	Behavioral: Sleep scheduling 8 hours vs. 6 hours time in bed for two weeks Drug: Fluoxetine 20-40 mg fluoxetine daily for 8 weeks Other Name: Prozac
Active Comparator: Early sleep deprivation 6 hours time in bed plus medication	Behavioral: Sleep scheduling 8 hours vs. 6 hours time in bed for two weeks Drug: Fluoxetine 20-40 mg fluoxetine daily for 8 weeks Other Name: Prozac
Active Comparator: Late sleep deprivation 6 hours time in bed plus medication	Behavioral: Sleep scheduling 8 hours vs. 6 hours time in bed for two weeks 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 early and late 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 keep one of 3 sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), early partial sleep deprivation (6 hours time in bed, with bedtime delayed by 2 hours), or late partial sleep deprivation (6 hours time in bed, with wake time advanced by 2 hours). 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

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

Contacts

Contact: Leslie Swanson, Ph.D.	734-764-2256	lmswan@umich.edu
Contact: J. Todd Arnedt, Ph.D.	734-764-2256	tarnedt@umich.edu

Locations

United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Leslie Swanson, Ph.D. 734-764-2256 lmswan@umich.edu

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
Last Updated:	March 1, 2012
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
Mood Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Fluoxetine

Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013