Slow-wave Sleep Deprivation in Depression

NCT ID: NCT01189591

Last Updated: 2017-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-08-31

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

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sleep deprivation

Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder

Group Type: EXPERIMENTAL

Slow-wave deprivation

Intervention Type: DEVICE

Using acoustic tones to suppress slow-wave sleep

Interventions

Slow-wave deprivation

Using acoustic tones to suppress slow-wave sleep

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruth M Benca, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Wisconsin Center for Sleep Medicine and Research

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

P20MH077967 NIH grant number

Identifier Type: -

Identifier Source: secondary_id

H-2007-0150

Identifier Type: OTHER

Identifier Source: secondary_id

P20MH077967

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-0019

Identifier Type: -

Identifier Source: org_study_id