NCT00291239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

2.8 years

First QC Date

February 9, 2006

Last Update Submit

April 2, 2009

Conditions

Major Depression

Outcome Measures

Primary Outcomes (2)

  • cognition

  • cytokine concentration

Secondary Outcomes (1)

  • clinical improvement

Interventions

partial sleep deprivationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression
  • Informed consent

You may not qualify if:

  • Known epilepsy or previous unexplained loss of consciousness after sleep deprivation
  • Bipolar disorder
  • Acute or chronic inflammatory diseases
  • Psychosis
  • Suicidal tendency
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentrum für Integrative Psychiatrie

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Dunja Hinze-Selch, MD

    Zentrum für Integrative Psychiatrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 13, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

July 1, 2009

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

DE(1)