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

This study is currently recruiting participants.

Verified by Zentrum für Integrative Psychiatrie, June 2007

Sponsors and Collaborators:	Zentrum für Integrative Psychiatrie German Research Foundation
Information provided by:	Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:	NCT00291239

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 IV

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
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 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291239

Contacts

Contact: Paul C Baier, MD	+49-431-9900 ext 4168	p.baier@zip-kiel.de
Contact: Dunja Hinze-Selch, MD	+49-431-9900 ext 2554	d.hinze-selch@zip-kiel.de

Locations

Germany
Zentrum für Integrative Psychiatrie	Recruiting
Kiel, Germany, 24105
Contact: Dunja Hinze-Selch, MD +49-431-9900 ext 2681 d.hinze-selch@zip-kiel.de
Principal Investigator: Dunja Hinze-Selch, MD

Sponsors and Collaborators

Zentrum für Integrative Psychiatrie

German Research Foundation

Investigators

Principal Investigator:

Dunja Hinze-Selch, MD

Zentrum für Integrative Psychiatrie

More Information

Study ID Numbers:	WADE, DFG-SFB 654, C5 "IL-6-MDE"
Study First Received:	February 9, 2006
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00291239
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Signs and Symptoms
Depression
Mental Disorders
Mood Disorders
Neurologic Manifestations
Sleep Disorders

Dyssomnias
Depressive Disorder, Major
Depressive Disorder
Sleep Deprivation
Behavioral Symptoms

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009