Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 11:42 AM
Study NCT ID:
NCT00745966
Status:
COMPLETED
Last Update Posted:
2008-10-06
First Post:
2008-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'lastUpdateSubmitDate': '2008-10-03', 'studyFirstSubmitDate': '2008-09-02', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change from the baseline to week 8 in Short Form of the Quality of Life Enjoyment and satisfaction Questionnaire (Q-LES-Q) score'}], 'secondaryOutcomes': [{'measure': 'The change from the baseline to week 8 in CGI-BP and GAF scale score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar', 'atypical antipsychotics', 'quality of life', 'observational'], 'conditions': ['Naturalistic', 'Observational']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent.\n* Meet DSM-IV-TR criteria for bipolar disorder (bipolar I disorder, bipolar II disorder) at the time of baseline.\n\nExclusion Criteria:\n\n* Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history.\n* Known intolerance for or lack of response to atypical antipsychotics , as judged by the investigator."}, 'identificationModule': {'nctId': 'NCT00745966', 'acronym': 'POLE', 'briefTitle': 'Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder', 'orgStudyIdInfo': {'id': 'NIS-NKR-SER-2008/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kyunggi-do', 'state': 'Choonchun-si', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Daegu', 'state': 'Joong-gu', 'country': 'South Korea', 'facility': 'RFesearch Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Joon-Woo Bahn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazeneca, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Joon-Woo Bahn', 'oldOrganization': 'AstraZeneca'}}}}