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

Major Depression Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00291239
• Other study ID #: WADE
• Secondary ID: DFG-SFB 654, C5
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 9, 2006
• Last updated: April 2, 2009
• Start date: February 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2009
• Source: Zentrum für Integrative Psychiatrie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Sleep Deprivation

Intervention

Behavioral:
• partial sleep deprivation

Locations

Country	Name	City	State
Germany	Zentrum für Integrative Psychiatrie	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Zentrum für Integrative Psychiatrie	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognition
Primary	cytokine concentration
Secondary	clinical improvement