DepressionNCT00818506
Associations Between Depression and Cardiovascular Disease - a Study of Patients With Late Onset Depression
An observational study of Depression and Major Depressive Disorder, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Major Depressive Disorder, Cardiovascular Disease
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Psychiatric treatment facilities (e.g. psychiatric hospital, private psychiatrist).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center of Psychiatric Research, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Associations Between Depression and Cardiovascular Disease in Patients With Late Onset, Single Episode Major Depressive Disorder
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.
- Keywords
- Depression, Major depressive disorder, Coronary artery disease, White Matter Hyperintensities, White Matter Lesions, Coronary artery calcification
- Medical subject headings
- Depression, Depressive Disorder, Major, Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startMar 2009
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Vejle Hospital, Danish National Research Foundation, Aarhus University Hospital, Augustinus Fonden
- Responsible party
- Sponsor
- Investigators
- Poul Videbech, Professor, M.D., Dr.Med., Study director, Center of Psychiatric Research, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818506
- Sponsor's protocol ID
- CPF-TAD-1
- Status last verified
- Nov 2012
- First submitted
- 6 Jan 2009
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Depression and Cardiovascular Disease in Patients With Late Onset, Single Episode Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00818506
- Acronym / sponsor ID
- CPF-TAD-1
- Keywords
- Depression, Major depressive disorder, Coronary artery disease, White Matter Hyperintensities, White Matter Lesions, Coronary artery calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Vejle Hospital, Danish National Research Foundation, Aarhus University Hospital, Augustinus Fonden
- Study start
- Mar 2009
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric treatment facilities (e.g. psychiatric hospital, private psychiatrist).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Center of Psychiatric Research, Aarhus University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poul Videbech, Professor, M.D., Dr.Med. study director
Center of Psychiatric Research, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Major Depressive Disorder, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.