Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 6:05 AM
Study NCT ID:
NCT01514435
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2012-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-17', 'studyFirstSubmitDate': '2012-01-11', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain glucose metabolism measured by FDG-PET', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'FDG-PET', 'Electroconvulsive therapy', 'glucose metabolism'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '17444078', 'type': 'BACKGROUND', 'citation': 'Berlim MT, Turecki G. Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods. Can J Psychiatry. 2007 Jan;52(1):46-54. doi: 10.1177/070674370705200108.'}, {'pmid': '17662472', 'type': 'BACKGROUND', 'citation': 'Schmidt EZ, Reininghaus B, Enzinger C, Ebner C, Hofmann P, Kapfhammer HP. Changes in brain metabolism after ECT-positron emission tomography in the assessment of changes in glucose metabolism subsequent to electroconvulsive therapy--lessons, limitations and future applications. J Affect Disord. 2008 Feb;106(1-2):203-8. doi: 10.1016/j.jad.2007.06.009. Epub 2007 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'There exist already a few studies that have measured changes of brain metabolism pre and post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all performed in a small number of patients and used different methodologies. It is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 Schmidt,E.Z. 2008}}.\n\nIn patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur after treatment with ECT and (b) whether these correlate with the clinical amelioration of symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at the end of treatment.\n\nPatients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively asked for participation in this study. Patients had to be between 18 and 80 years old and to be physically healthy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical indication for ECT\n* treatment refractory depressive episode\n* age 18-85 y\n\nExclusion Criteria:\n\n* addiction as a first diagnosis\n* dementia'}, 'identificationModule': {'nctId': 'NCT01514435', 'briefTitle': 'Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study', 'orgStudyIdInfo': {'id': 'BRECT-2006-PET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECT verum group', 'description': 'Patients with treatment refractory depression treated with ECT', 'interventionNames': ['Device: Electroconvulsive therapy', 'Device: 18-Fluoro-desoxy-glucose positron emission tomography']}], 'interventions': [{'name': 'Electroconvulsive therapy', 'type': 'DEVICE', 'otherNames': ['no other names'], 'description': 'treatment for major depression', 'armGroupLabels': ['ECT verum group']}, {'name': '18-Fluoro-desoxy-glucose positron emission tomography', 'type': 'DEVICE', 'otherNames': ['no other names'], 'description': 'intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min.\n\nIt´s a neuroimaging technique.', 'armGroupLabels': ['ECT verum group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University Graz; Department for Psychiatry', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Bernd Reininghaus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}