Major DepressionNCT00260468
Brain Abnormalities in Late-Onset Major Depression
An observational study of Major Depression, run by University of Aarhus at 1 site in Denmark.
Trial summary
The objective of this project is to examine the state of the brain in people over 50 years old suffering from late-onset depression by means of an extensive clinical assessment programme, including magnetic resonance imaging (MRI), neuropsychological testing, neurological examination, eye examination as well as blood… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Clinical examination program
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Dec 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Subjects with first-episode late-onset major depression from psychiatric hospital or clinic 2. Healthy controls
Who may be able to join
- first time major depression
- age over 50 years
- Caucasian
- admitted at a psychiatric hospital or treated at a local psychiatric clinic in Aarhus Amt
Who cannot join
- major brain damage (e.g. stroke, epilepsy, trauma)
- major alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre for Psychiatric Research, Aarhus University Hospital
Risskov, DK-8240
About this study
Official title: Structural and Functional Cerebral Findings in Late-Onset Major Depression
The objective of this project is to examine the state of the brain in people over 50 years old suffering from late-onset depression by means of an extensive clinical assessment programme, including magnetic resonance imaging (MRI), neuropsychological testing, neurological examination, eye examination as well as blood and saliva samples. The results are to be compared with results from a control group matched for gender and age.
Read the detailed description
Major depression is a frequent and serious disorder with different prognoses and complications with respect to lack of treatment response, recurrence and suicide.
MRI of the brain can provide information about changes in the brain tissue with depression, e.g. lesions of nerve connections, small thrombi or changes in the blood flow. These changes appear primarily after the age of 50 and are seen in cases of diabetes and high blood pressure. Furthermore, the connection between disruptions in the body's stress response system and depression will be explored, which is very important since studies indicate that stress and depression can affect certain brain parts permanently. This will give us a better understanding of the connection between brain changes, neuropsychology and depression prognosis, which is decisive for accurate diagnostics, effective treatment and targeted prevention of the disease in the long run.
The project is part of a larger clinical assessment programme in the Neuropsychiatric Unit under the Centre for Basic Psychiatric Research, Aarhus Psychiatric Hospital, Denmark, which gives us unique possibilities of combining research and daily clinical work. The hope is in the future to be able to offer patients in the risk group better assessment and treatment to prevent complications and recurrence.
- Conditions
- Major Depression
- Being tested
- Clinical examination program
- Keywords
- Major depression, Magnetic resonance imaging, White matter lesions, Perfusion, Diffusion, Magnetization transfer, Vascular risk factors
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination programOther
Psychiatric/clinical interview MRI scan Blood samples Saliva samples Eye examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startNov 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council, Bayer
- Investigators
- Raben Rosenberg, Professor, MD, DrMedSc, Study director, Aarhus University HospitalVidebech Poul, Professor, MD, DrMedSc, Principal investigator, Aarhus University HospitalLeif Østergaard, Professor, MD, DrMedSc, PhD, Study chair, Center for Functionally Integrative Neuroscience (CFIN), Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260468
- Sponsor's protocol ID
- 20051050
- Status last verified
- Oct 2009
- First submitted
- 30 Nov 2005
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Cerebral Findings in Late-Onset Major Depression
- ClinicalTrials.gov ID
- NCT00260468
- Acronym / sponsor ID
- 20051050
- Conditions
- Major Depression
- Keywords
- Major depression, Magnetic resonance imaging, White matter lesions, Perfusion, Diffusion, Magnetization transfer, Vascular risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council, Bayer
- Study start
- Nov 2005
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Dec 2005 (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.
The objective of this project is to examine the state of the brain in people over 50 years old suffering from late-onset depression by means of an extensive clinical assessment programme, including magnetic resonance imaging (MRI), neuropsychological testing, neurological examination, eye examination as well as blood and saliva samples. The results are to be compared with results from a control group matched for gender and age.
Detailed description
Major depression is a frequent and serious disorder with different prognoses and complications with respect to lack of treatment response, recurrence and suicide.
MRI of the brain can provide information about changes in the brain tissue with depression, e.g. lesions of nerve connections, small thrombi or changes in the blood flow. These changes appear primarily after the age of 50 and are seen in cases of diabetes and high blood pressure. Furthermore, the connection between disruptions in the body's stress response system and depression will be explored, which is very important since studies indicate that stress and depression can affect certain brain parts permanently. This will give us a better understanding of the connection between brain changes, neuropsychology and depression prognosis, which is decisive for accurate diagnostics, effective treatment and targeted prevention of the disease in the long run.
The project is part of a larger clinical assessment programme in the Neuropsychiatric Unit under the Centre for Basic Psychiatric Research, Aarhus Psychiatric Hospital, Denmark, which gives us unique possibilities of combining research and daily clinical work. The hope is in the future to be able to offer patients in the risk group better assessment and treatment to prevent complications and recurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Subjects with first-episode late-onset major depression from psychiatric hospital or clinic 2. Healthy controls
Key inclusion criteria (4 listed)
- first time major depression
- age over 50 years
- Caucasian
- admitted at a psychiatric hospital or treated at a local psychiatric clinic in Aarhus Amt
Key exclusion criteria (2 listed)
- major brain damage (e.g. stroke, epilepsy, trauma)
- major alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examination programPsychiatric/clinical interview MRI scan Blood samples Saliva samples Eye examination | Other | – |
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 22 Oct 2009.
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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.
Raben Rosenberg, Professor, MD, DrMedSc study director
Aarhus University Hospital
Videbech Poul, Professor, MD, DrMedSc principal investigator
Aarhus University Hospital
Leif Østergaard, Professor, MD, DrMedSc, PhD study chair
Center for Functionally Integrative Neuroscience (CFIN), Aarhus University Hospital, Denmark
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 Major Depression, 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 4 inclusion and 2 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 22 Oct 2009. 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 22 Oct 2009.