Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT00613912
Status:
COMPLETED
Last Update Posted:
2011-11-21
First Post:
2008-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced MRI in Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-18', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in morphological and functional cerebral MRI findings in patients suffering from major depression', 'timeFrame': '6 months from first MRI in each patient'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'Depression is the most common psychiatric disorder.\n\n* 3-5% of a given population has major depression.\n* Less than 50% of the depressed in Denmark are diagnosed with major depression.\n* 25-50% of the depressed have a relative with major depression-underlying brain pathology?\n\nThe purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression', 'detailedDescription': '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.\n\nMR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg hospital-Århus University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who fulfil ICD-10´s criteria for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18\n\nExclusion Criteria:\n\n* If the patient has pacemaker or other magnetic devices\n* Pregnancy\n* Has had an operation in the brain\n* bipolar disorder'}, 'identificationModule': {'nctId': 'NCT00613912', 'briefTitle': 'Advanced MRI in Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression', 'orgStudyIdInfo': {'id': 'AUFF-2005-740-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Ambulant patients with major depression', 'interventionNames': ['Other: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'OTHER', 'otherNames': ['3 Tesla GE Scanner HDx'], 'description': '* Morphological sequences\n* Arterial Spin Labelling (Perfusion)\n* Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'Aalborg Hospital / Aarhus University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Elna-Marie B Larsson, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}