Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT00690859
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2008-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Recurrence in Bipolar Disorder 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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 595}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period', 'timeFrame': 'Every three months'}, {'measure': 'Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)', 'timeFrame': 'Every three months'}], 'secondaryOutcomes': [{'measure': 'Evaluation of factors that can predict functional outcomes', 'timeFrame': 'Every three months'}, {'measure': 'Description of Health services utilization (hospitalisations, primary care, treatments..)', 'timeFrame': 'Every three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar disorders', 'Predictors of recurrence'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Observational, prospective (1 year follow up), multicenter, non-interventional open label study in order to assess the factors that predict onset of mood disorders episodes (depression, mania, hypomania and mixed) in stabilized patients with bipolar disorder I or II in Spain. Other objectives are\n\n1. to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality\n2. to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms\n3. to evaluate the economical impact on health service of these patients (hospitalization, primary care, treatments…).\n\nTarget population is 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. The primary endpoint is the onset of mood disorders episodes (depression, mania, hypomania and mixed) during the follow-up period and evaluation of which factors predict onset of mood episodes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed of Bipolar Disorder I or II (DSM-IV-TR)\n* Patients Stabilized from at least 2 months who had a mood disorder episode (depression, mania, hypomania or mixed) in the last year.\n* To be attended by a psychiatric specialist\n\nExclusion Criteria:\n\n* Inability to participate in the study\n* To have taken part in other study in the last 6 months'}, 'identificationModule': {'nctId': 'NCT00690859', 'acronym': 'PREBIS', 'briefTitle': 'Predictors of Recurrence in Bipolar Disorder in Spain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain', 'orgStudyIdInfo': {'id': 'NIS-NES-DUM-2007/1'}}, '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': 'Victoria', 'state': 'Alava', 'country': 'Spain', 'facility': 'Research Site'}, {'city': 'Elda', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}, {'city': 'Torrevieja', 'state': 'Alicante', 'country': 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'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 28.11983, 'lon': -15.52325}}, {'city': 'Banaderos', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Research Site'}, {'city': 'Arganda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.30076, 'lon': -3.43722}}, {'city': 'Fuenlabrada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'city': 'Torrejón de Ardoz', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.45535, 'lon': -3.46973}}, {'city': 'Velez', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Research Site'}, {'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Gijón', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Mairena del Aljarafe', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.34461, 'lon': -6.06391}}, {'city': 'Foios', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.53333, 'lon': -0.35}}, {'city': 'Sagunto', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.68333, 'lon': -0.26667}}, {'city': 'Vilanova', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Research Site'}, {'city': 'Barakaldo', 'state': 'Vizacaya', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Zalla', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.23333, 'lon': -3.13333}}, {'city': 'Zamudio', 'state': 'Vizcaya', 'country': 'Spain', 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