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Completed

NCT Number: NCT01189591

Slow-wave Sleep Deprivation in Depression

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wisconsin Center for Sleep Medicine and Research

Madison, Wisconsin, 53719, United States

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slow-wave deprivation

Device

Using acoustic tones to suppress slow-wave sleep

Primary outcomes

  1. Hamilton Depression Scale

    Time frame: 24 hours

Secondary outcomes

  1. Inventory of Depressive Symptomology

    Time frame: 24 hours

    rating scale of mood

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2010
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.