Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 3:06 PM
Study NCT ID:
NCT01455961
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-19', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before, at and after the index date.', 'timeFrame': '1st of January 2009 to 31st of December 2010.'}], 'secondaryOutcomes': [{'measure': 'Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before and at the index date.', 'timeFrame': '1st of January 2009 to 31st of December 2010.'}, {'measure': 'Description of the detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD, including all drug treatment after the index date', 'timeFrame': '1st of January 2009 to 31st of December 2010.'}, {'measure': 'Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD, including all drug treatment before and at the index date', 'timeFrame': '1st of January 2009 to 31st of December 2010.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Real life setting', 'Bipolar Disorder', 'Registry based Data Base Audit'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '25653826', 'type': 'DERIVED', 'citation': 'Carlborg A, Thuresson M, Ferntoft L, Bodegard J. Characteristics of bipolar disorder patients treated with immediate- and extended-release quetiapine in a real clinical setting: a longitudinal, cohort study of 1761 patients. Ther Adv Psychopharmacol. 2015 Feb;5(1):13-21. doi: 10.1177/2045125314560740.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1139&filename=CSR-VD-NS-1101.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1139&filename=REED_NCT01455961_Redacted_protocol.pdf', 'label': 'Redacted\\_protocol'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the treatment pattern and patient characteristics in real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel IR in Sweden.', 'detailedDescription': 'An epidemiological registry study to evaluate clinical practice treatment in patients with Bipolar Disorder treated with quetiapine XR and/or quetiapine IR'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have been hospitalised in Sweden at least once since 1987 with a diagnosis during hospitalisation of Bipolar Disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of BD.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of bipolar disorder.'}, 'identificationModule': {'nctId': 'NCT01455961', 'acronym': 'REED', 'briefTitle': 'An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder Treated With Quetiapine XR and/or Quetiapine IR', 'orgStudyIdInfo': {'id': 'VD-NS-1101'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andreas Carlborg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet 171 76 Stockholm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}