Major Depressive DisorderNCT01189591
Slow-wave Sleep Deprivation in Depression
A study testing Slow-wave deprivation in people with Major Depressive Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Slow-wave deprivation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wisconsin Center for Sleep Medicine and Research
Madison, Wisconsin, 53719
About this study
Official title: Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder
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.
Read the detailed description
see above
- Conditions
- Major Depressive Disorder
- Being tested
- Slow-wave deprivation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-wave deprivationDevice
Using acoustic tones to suppress slow-wave sleep
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | Slow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder Receives: Device: Slow-wave deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
Measured: 24 hours
Secondary outcomes (1)
Inventory of Depressive Symptomology
rating scale of mood
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ruth M Benca, M.D., Ph.D, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189591
- Sponsor's protocol ID
- 2013-0019
- Other IDs
- P20MH077967 NIH grant number, H-2007-0150, P20MH077967
- Status last verified
- Nov 2017
- First submitted
- 25 Aug 2010
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow-wave Sleep Deprivation as a Possible Treatment for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01189591
- Acronym / sponsor ID
- 2013-0019
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Device: Slow-wave deprivationSlow-wave sleep deprivation for one night as an experimental treatment for major depressive disorder |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Among the inclusion criteria will be:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-wave deprivationUsing acoustic tones to suppress slow-wave sleep | Device | Sleep deprivation |
Primary outcome
Hamilton Depression Scale
Time frame: 24 hours
1 secondary outcome
Inventory of Depressive Symptomology
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth M Benca, M.D., Ph.D principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-wave deprivation in people with Major Depressive Disorder, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.