Slow-wave Sleep Deprivation in Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189591
• Other study ID #: 2013-0019
• Secondary ID: P20MH077967 NIH
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: November 6, 2017
• Start date: June 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Sleep Deprivation

Intervention

Device:
• Slow-wave deprivation
Using acoustic tones to suppress slow-wave sleep

Locations

Country	Name	City	State
United States	Wisconsin Center for Sleep Medicine and Research	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale		24 hours
Secondary	Inventory of Depressive Symptomology	rating scale of mood	24 hours