Depressive Disorder, MajorNCT00613912
Advanced MRI in Major Depression
An observational study of Depressive Disorder, Major, run by University of Aarhus at 1 site in Denmark.
Trial summary
Depression is the most common psychiatric disorder. 3-5% of a given population has major depression. Less than 50% of the depressed in Denmark are diagnosed with major depression. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Jun 2011
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg hospital-Århus University Hospital.
Who may be able to join
- Patients who fulfil ICD-10´s criteria for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18
Who cannot join
- If the patient has pacemaker or other magnetic devices
- Pregnancy
- Has had an operation in the brain
- bipolar disorder
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg Hospital / Aarhus University Hospital
Aalborg, Jutland, 9000
About this study
Official title: Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression
Depression is the most common psychiatric disorder.
- 3-5% of a given population has major depression.
- Less than 50% of the depressed in Denmark are diagnosed with major depression.
- 25-50% of the depressed have a relative with major depression-underlying brain pathology?
The purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression
Read the detailed description
Previous studies within major depression, have often included hospitalized patients with severe symptoms and imaging have been performed with PET and SPECT, which uses ionizing radiation. This study focus on ambulant patients(with or without medication/ECT treatment), to find patients in an earlier stage. Cerebral perfusion with the MR sequence Arterial Spin Labelling, concentrations of different metabolites with MR spectroscopy and brain volumetry with BRAVO 3D T1 ax will be performed.
MR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.
- Conditions
- Depressive Disorder, Major
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain
- 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.
Magnetic Resonance ImagingOther
Also called 3 Tesla GE Scanner HDx
- Morphological sequences
- Arterial Spin Labelling (Perfusion)
- Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter
| Study group | Role | What they receive |
|---|---|---|
| A | Ambulant patients with major depression Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in morphological and functional cerebral MRI findings in patients suffering from major depression
Measured: 6 months from first MRI in each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elna-Marie B Larsson, Professor, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613912
- Sponsor's protocol ID
- AUFF-2005-740-004
- Status last verified
- Nov 2011
- First submitted
- 31 Jan 2008
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00613912
- Acronym / sponsor ID
- AUFF-2005-740-004
- Conditions
- Depressive Disorder, Major
- Keywords
- Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Feb 2008 (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.
Depression is the most common psychiatric disorder.
- 3-5% of a given population has major depression.
- Less than 50% of the depressed in Denmark are diagnosed with major depression.
- 25-50% of the depressed have a relative with major depression-underlying brain pathology?
The purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression
Detailed description
Previous studies within major depression, have often included hospitalized patients with severe symptoms and imaging have been performed with PET and SPECT, which uses ionizing radiation. This study focus on ambulant patients(with or without medication/ECT treatment), to find patients in an earlier stage. Cerebral perfusion with the MR sequence Arterial Spin Labelling, concentrations of different metabolites with MR spectroscopy and brain volumetry with BRAVO 3D T1 ax will be performed.
MR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Magnetic Resonance ImagingAmbulant patients with major depression |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg hospital-Århus University Hospital.
Key inclusion criteria (1 listed)
- Patients who fulfil ICD-10´s criteria for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18
Key exclusion criteria (4 listed)
- If the patient has pacemaker or other magnetic devices
- Pregnancy
- Has had an operation in the brain
- bipolar disorder
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: 3 Tesla GE Scanner HDx* Morphological sequences * Arterial Spin Labelling (Perfusion) * Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter | Other | A |
Primary outcome
Differences in morphological and functional cerebral MRI findings in patients suffering from major depression
Time frame: 6 months from first MRI in each patient
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 2011.
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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.
Elna-Marie B Larsson, Professor principal investigator
Uppsala 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 Depressive Disorder, Major, 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 1 inclusion and 4 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 2011. 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.
What does the primary outcome measure?
Differences in morphological and functional cerebral MRI findings in patients suffering from major depression (time frame: 6 months from first MRI in each patient). It is what the study was designed to measure, not a finding.
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 2011.