Associations Between Depression and Cardiovascular Diseas... | NCT00818506

Studies
Associations Between Depression and Cardiovascular Disease - a Study of Patients With Late Onset Depression

NCT00818506

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 21, 2012Estimated

Enrollment

55Actual

Phase

Not provided

Conditions

Depression
Major Depressive Disorder
Cardiovascular Disease
Coronary Artery Disease

Interventions

Not provided

Countries

Denmark

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

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Not provided

Completion Date

Jun 2012Actual

First Submitted Date

Jan 6, 2009

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

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

Nov 20, 2012

Last Update Posted Date

Nov 21, 2012Estimated

Name	Class
The Ministry of Science, Technology and Innovation, Denmark	OTHER_GOV
Vejle Hospital	OTHER
Danish National Research Foundation	OTHER
Aarhus University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Studies show that depression is a risk factor for the development of coronary artery disease (CAD). Furthermore there is an increased occurrence of depression in patients with CAD. Among other mechanisms atherosclerosis is believed to play a central role regarding these notable associations between depression and CAD. Moreover, patients with late onset major depression have an increased number of small lesions found in the white matter of the brain, the so-called white matter lesions. The main goal of this project is to examine if CAD is associated with depression and/or white matter lesions. CAD is evaluated using coronary CT angiography. Depression is evaluated using a semi-structured diagnostic interview. White matter lesions are quantified using cerebral magnetic resonance.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Late onset MDD		Patients with major depressive disorder between 50 and 70 years of age that did not suffer from depression before the age of 50.
Controls		Healthy controls (matched for age, sex, and tobacco use status)

Interventions

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Submitted to psychiatric hospital, district psychiatry or private psychiatrist because of major depressive disorder.
Meets the criteria for Major Depressive Disorder, Single Episode as defined in the Diagnostic and Statistical Manual, fourth edition (DSM-IV) and the International Classification of Diseases (ICD-10).
Age 50-70 years.
Written informed consent.
Caucasian.

EXCLUSION CRITERIA:

Known, or anamnestic/objective signs of, organic brain disease.
Organic, including symptomatic, mental disorders as (ICD-10: F00-F09).
Dependence syndrome within the last 5 years (ICD-10: F1x.2) or current harmful use (ICD-10: F1x.1) of alcohol or other psychoactive substances.
Schizophrenia, schizotypal and delusional disorders (ICD-10: F20-F29).
Subject to force of law according to the danish law on psychiatry.
Present risk of suicide.
Previous cranial trauma resulting in unconsciousness for more than 2 minutes.
Medical history of renal failure.
Other conditions which contraindicate specific procedures in the project.
Other conditions deemed to prevent the subject from completing the examination program.
Does not want to participate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Psychiatric treatment facilities (e.g. psychiatric hospital, private psychiatrist).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poul Videbech, Professor, M.D., Dr.Med.	Center of Psychiatric Research, Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Psychiatric Research, Aarhus University Hospital		Aarhus		8200	Denmark

Label	URL
Center of Psychiatric Research, Aarhus University Hospital	View source

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D003865	Depressive Disorder, Major
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D003866	Depressive Disorder
D019964	Mood Disorders

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Browse Branches

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