NCT00818506

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

First QC Date

January 6, 2009

Last Update Submit

November 20, 2012

Conditions

DepressionMajor Depressive DisorderCardiovascular DiseaseCoronary Artery Disease

Keywords

DepressionMajor depressive disorderCoronary artery diseaseWhite Matter HyperintensitiesWhite Matter LesionsCoronary artery calcification

Study Arms (2)

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)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Psychiatric Research, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorCardiovascular DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Poul Videbech, Professor, M.D., Dr.Med.

    Center of Psychiatric Research, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

March 1, 2009

Study Completion

June 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

DK(1)