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Slow-wave Sleep Deprivation in Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189591
First Posted: August 26, 2010
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention
Major Depressive Disorder Device: Slow-wave deprivation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Basic Science
Official Title: Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Hamilton Depression Scale [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Inventory of Depressive Symptomology [ Time Frame: 24 hours ]
    rating scale of mood


Enrollment: 25
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
see above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01189591


Locations
United States, Wisconsin
Wisconsin Center for Sleep Medicine and Research
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ruth M Benca, M.D., Ph.D University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01189591     History of Changes
Other Study ID Numbers: 2013-0019
P20MH077967 NIH grant number
H-2007-0150 ( Other Identifier: UW IRB )
P20MH077967 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2010
First Posted: August 26, 2010
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Sleep Deprivation
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms