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Slow-wave Deprivation in Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01189591
First received: August 25, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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 Deprivation as a Possible Treatment for Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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


Estimated Enrollment: 48
Study Start Date: June 2009
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Slow-wave deprivation
    Using acoustic tones to suppress slow-wave sleep
  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 criteria (as determined by the Structured Clinical Interview for DSM-IV), 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-TR 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189591

Contacts
Contact: Stephanie Jones, Ph.D 608 263 3447 sgjones2@wisc.edu

Locations
United States, Wisconsin
Wisconsin Center for Sleep Medicine and Research Recruiting
Madison, Wisconsin, United States, 53719
Contact: Jones, Ph.D         sgjones2@wisc.edu    
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

No publications provided

Responsible Party: Ruth M. Benca M.D, Ph.D, Giulio Tononi, M.D, Ph.d, University of Wisconsin
ClinicalTrials.gov Identifier: NCT01189591     History of Changes
Other Study ID Numbers: 2007-0150
Study First Received: August 25, 2010
Last Updated: August 25, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013