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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:
NCT00291239
First received: February 9, 2006
Last updated: April 2, 2009
Last verified: April 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00291239     History of Changes
Other Study ID Numbers: WADE, DFG-SFB 654, C5 "IL-6-MDE"
Study First Received: February 9, 2006
Last Updated: April 2, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 20, 2014