Status:
COMPLETED
Slow-wave Sleep Deprivation in Depression
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-35 years
Phase:
NA
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...
Detailed Description
see above
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01189591
Start Date
June 1 2009
End Date
August 1 2011
Last Update
November 8 2017
Active Locations (1)
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1
Wisconsin Center for Sleep Medicine and Research
Madison, Wisconsin, United States, 53719