Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-14 @ 2:14 AM
Study NCT ID:
NCT00757328
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2008-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Clinical Practice in Bipolar Depression in Spain
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-16', 'studyFirstSubmitDate': '2008-09-22', 'studyFirstSubmitQcDate': '2008-09-22', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line', 'timeFrame': "Last two bipolar episodes recorded in tha patient's clinical history"}], 'secondaryOutcomes': [{'measure': 'Non pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line', 'timeFrame': "Last two bipolar episodes recorded in tha patient's clinical history"}, {'measure': "Description of the course of the patients' bipolar disorder", 'timeFrame': "Course of the disorder recorded in the patient's clinical history"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar depression Treatment'], 'conditions': ['Bipolar Depression']}, 'descriptionModule': {'briefSummary': 'Cross-sectional observational, non interventional, multicenter study of retrospective review of clinical records of ambulatory followed up bipolar patients in order to record epidemiological aspects of the course of the disorder, more specifically of bipolar depression episodes and the clinical practices carried out by psychiatrists in Spain in bipolar depressive episodes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult bipolar I or II patients with no more than 10 years of evolution of the bipolar disorder, with continued assistance in ambulatory settings and whose psychiatrist has recorded the treatment strategy used for of at least 2 depressive episodes within the patients' bipolar condition in the clinical history", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed of Bipolar Disorder I or II (DSM-IV-TR) in ambulatory follow-up\n* Evolution of the bipolar diagnoses inferior to 10 years\n* Having recorded in the patient's clinical history the clinical management of at least two bipolar depressive episodes\n\nExclusion Criteria:\n\n* Not having enough information recorded in the clinical history for the essential measurement variables\n* To have taken part in other study in the last 6 months"}, 'identificationModule': {'nctId': 'NCT00757328', 'acronym': 'EPIDEP', 'briefTitle': 'Treatment Clinical Practice in Bipolar Depression in Spain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'EPIDEP. Epidemiologic Study in Bipolar Depression: Evaluation of the Usual Clinical Practice of Psychiatrists in Spain', 'orgStudyIdInfo': {'id': 'NIS-NES-DUM-2008/3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Donostia / San Sebastian', 'state': 'Guipuzcoa', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'city': 'Santiago C.', 'state': 'La Coruna', 'country': 'Spain', 'facility': 'Research Site'}, {'city': 'Palma M', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Research Site'}, {'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'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': 'Cadiz', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Huesca', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.13615, 'lon': -0.4087}}, {'city': 'Las Palmas', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'León', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'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': 'Seville', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}