Back to results

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

Primary Purpose

Major Depression

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

partial sleep deprivation

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zentrum für Integrative Psychiatrie

Outcomes

Primary Outcome Measures

cognition

cytokine concentration

Secondary Outcome Measures

clinical improvement

Full Information

NCT ID

NCT00291239

First Posted

February 9, 2006

Last Updated

April 2, 2009

Sponsor

Zentrum für Integrative Psychiatrie

Collaborators

German Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00291239

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Zentrum für Integrative Psychiatrie

Collaborators

German Research Foundation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

partial sleep deprivation

Primary Outcome Measure Information:

Title

cognition

Title

cytokine concentration

Secondary Outcome Measure Information:

Title

clinical improvement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dunja Hinze-Selch, MD

Organizational Affiliation

Zentrum für Integrative Psychiatrie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zentrum für Integrative Psychiatrie

City

Kiel

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs