Effect of Partial Sleep Deprivation on Cognition and Cytokines in Individuals With Major Depression
April 2, 2009 updated by: Zentrum für Integrative Psychiatrie
Phase 4 Study on the Effect of Partial Sleep Deprivation on Cognition and the IL-6-gp130-System in Individuals With Major Depression
40 patients with the diagnosis of major depression are included.
There are two interventions: partial sleep deprivation (PSD) and normal night sleep (CTRL).
Patients are randomly assigned to PSD-(2 undisturbed nights)-CTRL or CTRL-(2 undisturbed nights)-PSD.
Cytokine-status, neuropsychological and psychopathometric status are assessed pre and post each interventional and control condition.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kiel, Germany, 24105
- Zentrum für Integrative Psychiatrie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Major depression
- Informed consent
Exclusion Criteria:
- Known epilepsy or previous unexplained loss of consciousness after sleep deprivation
- Bipolar disorder
- Acute or chronic inflammatory diseases
- Psychosis
- Suicidal tendency
- Pregnancy or nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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cognition
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cytokine concentration
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Secondary Outcome Measures
Outcome Measure |
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clinical improvement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Anticipated)
July 1, 2009
Study Registration Dates
First Submitted
February 9, 2006
First Submitted That Met QC Criteria
February 10, 2006
First Posted (Estimate)
February 13, 2006
Study Record Updates
Last Update Posted (Estimate)
April 3, 2009
Last Update Submitted That Met QC Criteria
April 2, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WADE
- DFG-SFB 654, C5 "IL-6-MDE"
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.