Slow-wave Sleep Deprivation in Depression

NCT01189591 | Completed

• 4 other identifiers: 2013-0019P20MH077967 NIH grant numberH-2007-0150P20MH077967
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale

  24 hours

Secondary Outcomes (1)

• Inventory of Depressive Symptomology

  24 hours

Study Arms (1)

Sleep deprivation

EXPERIMENTAL

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

Device: Slow-wave deprivation

Interventions

Slow-wave deprivation DEVICE

Using acoustic tones to suppress slow-wave sleep

Sleep deprivation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Wisconsin Center for Sleep Medicine and Research

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ruth M Benca, M.D., Ph.D

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: June 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

US (1)