Slow-wave Sleep Deprivation in Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Slow-wave deprivation

• Registration Number: NCT01189591
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

see above

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep deprivation	Slow-wave deprivation	Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale	24 hours

Secondary Outcome Measures

Name	Time	Method
Inventory of Depressive Symptomology	24 hours	rating scale of mood

Trial Locations

Locations (1)

Wisconsin Center for Sleep Medicine and Research; 🇺🇸 Madison, Wisconsin, United States