Slow-wave Sleep Deprivation in Depression | NCT01189591

Studies
Slow-wave Sleep Deprivation in Depression

NCT01189591

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Slow-wave deprivation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P20MH077967 NIH grant number
H-2007-0150	Other Identifier	UW IRB
P20MH077967	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 25, 2010

First Submission Date that Met QC Criteria

Aug 25, 2010

First Posted Date

Aug 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Name	Class
National Institutes of Health (NIH)	NIH

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep deprivation	Experimental	Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder	Device: Slow-wave deprivation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slow-wave deprivation	Device	Using acoustic tones to suppress slow-wave sleep	Sleep deprivation

Measure	Description	Time Frame
Hamilton Depression Scale		24 hours

Measure	Description	Time Frame
Inventory of Depressive Symptomology	rating scale of mood	24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders