Clinical trial NCT01189591: Slow-wave Sleep Deprivation in Depression
Official title: Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-08-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Scale
timeFrame: 24 hours
Secondary outcomes:
measure: Inventory of Depressive Symptomology
timeFrame: 24 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: Wisconsin Center for Sleep Medicine and Research
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ruth M Benca, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: