search
Back to results

Slow-wave Sleep Deprivation in Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow-wave deprivation
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wisconsin Center for Sleep Medicine and Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep deprivation

Arm Description

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

Outcomes

Primary Outcome Measures

Hamilton Depression Scale

Secondary Outcome Measures

Inventory of Depressive Symptomology
rating scale of mood

Full Information

First Posted
August 25, 2010
Last Updated
November 6, 2017
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01189591
Brief Title
Slow-wave Sleep Deprivation in Depression
Official Title
Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder
Intervention Type
Device
Intervention Name(s)
Slow-wave deprivation
Intervention Description
Using acoustic tones to suppress slow-wave sleep
Primary Outcome Measure Information:
Title
Hamilton Depression Scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Inventory of Depressive Symptomology
Description
rating scale of mood
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth M Benca, M.D., Ph.D
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wisconsin Center for Sleep Medicine and Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Slow-wave Sleep Deprivation in Depression

We'll reach out to this number within 24 hrs