This trial is active, not recruiting.

Condition major depression
Treatment partial sleep deprivation
Phase phase 4
Sponsor Zentrum für Integrative Psychiatrie
Collaborator German Research Foundation
Start date February 2006
End date December 2008
Trial size 40 participants
Trial identifier NCT00291239, DFG-SFB 654, C5 "IL-6-MDE", WADE


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment

Primary Outcomes

time frame:
cytokine concentration
time frame:

Secondary Outcomes

clinical improvement
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Dunja Hinze-Selch, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Zentrum für Integrative Psychiatrie.