Effect of Partial Sleep Deprivation on Cognition and Cyto... | NCT00291239

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

NCT00291239

Sponsor

Zentrum für Integrative Psychiatrie

Status

Unknown status

Last Update Posted

Apr 3, 2009Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Major Depression

Interventions

partial sleep deprivation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DFG-SFB 654, C5 "IL-6-MDE"

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Jul 2009Estimated

First Submitted Date

Feb 9, 2006

First Submission Date that Met QC Criteria

Feb 10, 2006

First Posted Date

Feb 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2009

Last Update Posted Date

Apr 3, 2009Estimated

Name	Class
German Research Foundation	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
partial sleep deprivation	Behavioral

Measure	Description	Time Frame
clinical improvement

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dunja Hinze-Selch, MD	Zentrum für Integrative Psychiatrie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zentrum für Integrative Psychiatrie		Kiel		24105	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided