Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT00951132
Status:
WITHDRAWN
Last Update Posted:
2023-02-02
First Post:
2009-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Failure to include patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean SUV of large arteries', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Peripheral endothelial function (pulse wave amplitude)', 'timeFrame': '3 months'}, {'measure': 'Circulatory proinflammatory markers', 'timeFrame': '3 months'}, {'measure': 'Heart rate variability', 'timeFrame': '3 months'}, {'measure': 'Depressive symptoms', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammation', 'Atherosclerosis', 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.', 'detailedDescription': 'Depression is associated with increased risk of cardiovascular disease, in which one possible mechanism is systemic inflammation. Further, patients at high risk of cardiovascular disease, rosuvastatin decreases the risk, especially among patients with increased inflammation. This is a proof-of-concept study to investigate whether the antiinflammatory effect of rosuvastatin is similar in depressive as in patients with cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persisting self-reported depressive symptoms \\> 5 weeks\n* Indications of aortic atherosclerosis on PET/CT\n\nExclusion Criteria:\n\n* Clinical indication of statin use.\n* Contraindication of statins, or of PET/CT and MRI.\n* Established cardiovascular disease.\n* Bipolar disorder og comorbid psychosis.'}, 'identificationModule': {'nctId': 'NCT00951132', 'acronym': 'DECAMERONE', 'briefTitle': 'Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy', 'orgStudyIdInfo': {'id': 'AHUSPP0651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Rosuvastatin', 'interventionNames': ['Drug: rosuvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'rosuvastatin', 'type': 'DRUG', 'description': '10mg tablets, once daily in three months', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablet, once daily, three months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lorenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Akershus University Hospital'}], 'overallOfficials': [{'name': 'Torbjorn Omland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Torbjorn Omland', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}