Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00927420
Status:
COMPLETED
Last Update Posted:
2009-10-30
First Post:
2009-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-29', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morisky-Green Scale', 'timeFrame': 'Once, at the visit moment'}, {'measure': 'Drug Attitude Inventory Scale (DAI-10)', 'timeFrame': 'Once, at the visit moment'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M)', 'timeFrame': 'Once, at the visit moment'}, {'measure': 'Functioning Assessment Short Test (FAST)', 'timeFrame': 'Once, at the visit moment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar disorder', 'adherence', 'treatment', 'real life practice'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with bipolar disorder I or II DSM-IV\n* Patients treated with at least one oral antipsychotic\n* Subjects able to read and write\n\nExclusion Criteria:\n\n* Patients participating in clinical trials'}, 'identificationModule': {'nctId': 'NCT00927420', 'briefTitle': 'Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study', 'orgStudyIdInfo': {'id': 'NIS-NES-DUM-2009/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Las Palmas', 'state': 'Gran Canarias', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'Calahorra', 'state': 'La Rioja', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.30506, 'lon': -1.96521}}, {'city': 'Langreo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.29568, 'lon': -5.68416}}, {'city': 'San Cristóbal de La Laguna', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Almería', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Badajoz', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Elche', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'León', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Lleida', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Ourense', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Toledo', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Elisa Gil', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Spain EpidemiologyValue Demonstration Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}