Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT00584961
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)', 'timeFrame': '12 months'}, {'measure': 'Clinical Evolution of the Disease', 'timeFrame': '12 months'}, {'measure': 'Cardiovascular Risk', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Current pattern of treatment in Bipolar Disorder', 'timeFrame': '12 month'}, {'measure': 'Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder', 'timeFrame': '1 day'}, {'measure': 'Patient functional impairment', 'timeFrame': '12 months'}, {'measure': 'Patient quality of life', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281161&StudyName=BIMET%20Study%3A%20Evolution%20of%20Metabolic%20and%20Cardiovascular%20Risks%20Factors%20in%20Patients%20with%20Bipolar%20Disorder%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.\n\nTo analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.\n\nTo analyse the health status, quality of life and functioning/disability of patients.', 'detailedDescription': 'Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample. Patients \\>17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of Bipolar Disorder (DSM-IV TR)\n* Patients or their legal representatives have provided informed consent\n\nExclusion Criteria:\n\n* Patients are unable to complete or to understand health questionnaires in Spanish language\n* Patients enrolled in clinical trials or other studies'}, 'identificationModule': {'nctId': 'NCT00584961', 'acronym': 'BIMET', 'briefTitle': 'BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder', 'orgStudyIdInfo': {'id': 'A1281161'}}, 'armsInterventionsModule': {'armGroups': [{'label': '600 patients', 'description': 'Patients with diagnosis of Bipolar Disorder (DSM-IV TR)', 'interventionNames': ['Other: non-interventional']}], 'interventions': [{'name': 'non-interventional', 'type': 'OTHER', 'description': 'non-interventional', 'armGroupLabels': ['600 patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}