Slow-wave Sleep Deprivation in Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01189591
First received: August 25, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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 Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inventory of Depressive Symptomology [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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: NCT01189591

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01189591     History of Changes
Other Study ID Numbers: 2007-0150, P20MH077967 NIH grant number
Study First Received: August 25, 2010
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014