Advanced MRI in Major Depression
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2008 | ||||
| Last Updated Date | November 18, 2011 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Differences in morphological and functional cerebral MRI findings in patients suffering from major depression [ Time Frame: 6 months from first MRI in each patient ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00613912 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Advanced MRI in Major Depression | ||||
| Official Title ICMJE | Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression | ||||
| Brief Summary | Depression is the most common psychiatric disorder.
The purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg hospital-Århus University Hospital. |
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| Condition ICMJE | Depressive Disorder, Major | ||||
| Intervention ICMJE | Other: Magnetic Resonance Imaging
Other Name: 3 Tesla GE Scanner HDx |
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| Study Group/Cohort (s) | A
Ambulant patients with major depression
Intervention: Other: Magnetic Resonance Imaging |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 49 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00613912 | ||||
| Other Study ID Numbers ICMJE | AUFF-2005-740-004 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Aarhus | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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