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Effect of Partial Sleep Deprivation on Cognition and Cytokines in Individuals With Major Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291239
First Posted: February 13, 2006
Last Update Posted: April 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by:
Zentrum für Integrative Psychiatrie
  Purpose
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.

Condition Intervention Phase
Major Depression Behavioral: partial sleep deprivation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study on the Effect of Partial Sleep Deprivation on Cognition and the IL-6-gp130-System in Individuals With Major Depression

Further study details as provided by Zentrum für Integrative Psychiatrie:

Primary Outcome Measures:
  • cognition
  • cytokine concentration

Secondary Outcome Measures:
  • clinical improvement

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291239


Locations
Germany
Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
German Research Foundation
Investigators
Principal Investigator: Dunja Hinze-Selch, MD Zentrum für Integrative Psychiatrie
  More Information

ClinicalTrials.gov Identifier: NCT00291239     History of Changes
Other Study ID Numbers: WADE
DFG-SFB 654, C5 "IL-6-MDE"
First Submitted: February 9, 2006
First Posted: February 13, 2006
Last Update Posted: April 3, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Sleep Deprivation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms