Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 4:42 PM
Study NCT ID:
NCT01446692
Status:
COMPLETED
Last Update Posted:
2012-01-12
First Post:
2011-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Badalona Major Depressive Disorder Database Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-11', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the antidepressant strategies switches', 'timeFrame': '18 months', 'description': 'Number and type of treatment changes including combination, switch, or augmentation strategies.'}], 'secondaryOutcomes': [{'measure': 'Health care resource utilization', 'timeFrame': '18 months'}, {'measure': 'Health care costs', 'timeFrame': '18 months'}, {'measure': 'Hamilton Depression Rating Scale', 'timeFrame': '18 months'}, {'measure': 'Medication possession rate to evaluate adherence', 'timeFrame': '18 months'}, {'measure': 'Referral to psychiatrist office', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major depressive disorder', 'primary care', 'real-world evidence', 'database'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care', 'detailedDescription': 'Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)\n* At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009\n* 18 months of enrollment with medical and pharmacy records after index episode date'}, 'identificationModule': {'nctId': 'NCT01446692', 'briefTitle': 'Badalona Major Depressive Disorder Database Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study', 'orgStudyIdInfo': {'id': 'NIS-NES-XXX-2011/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suboptimal response'}, {'label': 'Patients with symptomatic remission'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}