Slow-wave Sleep Deprivation in Depression

Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder

Sleep deprivation can acutely reverse depressive symptoms in patients with major depression. Although underlying mechanisms of the antidepressant action in sleep deprivation are unclear, many of these observations can be explained by abnormal slow wave homeostasis. This study will test the prediction that selectively reducing slow waves during sleep (slow wave deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Slow-wave deprivation

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Wisconsin Center for Sleep Medicine and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Among the inclusion criteria will be:

  • age range 18-35 years
  • right handedness
  • major depressive disorder according to DSM-IV (Diagnostic and Statical Manual-Revision 4) criteria (as determined by the Structured Clinical Interview for Diagnostic and Statical Manual-Revision 4), with Hamilton Rating Scale for *Depression scores of at least 18 on the first 17 items
  • no psychotropic medications for at least 4 weeks
  • no joint and muscular di
  • normal hearing
  • regular bedtimes and sleep duration, no time zone shifts in the last three weeks.

Exclusion Criteria:

• Diabetes requiring insulin treatment
• A serious heart disorder or subjects who have had a heart attack within the last 3 months
• A diagnosis of cancer in the past 3 years and/or has active neoplastic disease
• Clinically significant abnormalities on pre-study physical exam or physician evaluation
• Subjects who meet DSM-IV (Diagnostic and Statical Manual-Revision 4) criteria for alcohol/drug abuse problems within the last six months or are currently using illegal drugs.
• Female subjects of child-bearing potential who are pregnant or planning to become pregnant.
• Women of child-bearing must be practicing a medically acceptable form of birth control.
• Women of childbearing potential will be questioned about pregnancy status and form of birth control to be used at each visit.
• Women who are unsure of their pregnancy status will be given a urine pregnancy test.
• Subjects taking investigational medications
• Subjects currently undergoing electroconvulsive therapy (ECT) or therapeutic transcranial magnetic stimulation (TMS).
• Subjects who regularly perform night or late evening shift work (e.g. - "second" or "third" shifts) or have had travel with time zone shifts >3h in the last 3 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep deprivation; Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder	Device: Slow-wave deprivation; Using acoustic tones to suppress slow-wave sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hamilton Depression Scale	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inventory of Depressive Symptomology	rating scale of mood	24 hours

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ruth M Benca, M.D., Ph.D, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Depression; Depressive Disorder; Depressive Disorder, Major; Sleep Deprivation
• Other Study ID Numbers: 2013-0019; P20MH077967 NIH grant number; H-2007-0150 (Other Identifier: UW IRB); P20MH077967 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No