Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 10:52 PM
Study NCT ID:
NCT01770704
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2013-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation Study of the Clinical Management of 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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-06', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episodes (depression, mania, hypomania or mixed).', 'timeFrame': 'Up to 21 months'}], 'secondaryOutcomes': [{'measure': 'Treatments received for Bipolar Disorder: medication time.', 'timeFrame': 'Up to 21 months'}, {'measure': 'Treatments received for Bipolar Disorder: medication classes.', 'timeFrame': 'Up to 21 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar disorder', 'Clinical management', 'Clinical outcomes'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '38592605', 'type': 'DERIVED', 'citation': 'Xu JJ, Zhu XQ, Liu S, Ding LY, Fu BB, Sun CC, Pan YL, Wang W, Zhang L. Sociodemographic, clinical and treatment characteristics of current rapid-cycling bipolar disorder: a multicenter Chinese study. Int J Bipolar Disord. 2024 Apr 9;12(1):11. doi: 10.1186/s40345-024-00332-z.'}, {'pmid': '37275983', 'type': 'DERIVED', 'citation': 'Shi X, Zhao Y, Yang H, Xu X, Fang Y, Yu X, Tan Q, Li H, Sun G, Wu H, Wang P, Yang J, Zhu X, Wang G, Zhang L. Factors associated with hospitalization times and length of stay in patients with bipolar disorder. Front Psychiatry. 2023 May 19;14:1140908. doi: 10.3389/fpsyt.2023.1140908. eCollection 2023.'}, {'pmid': '37226150', 'type': 'DERIVED', 'citation': 'Zhang ZF, Huang J, Zhu XQ, Yu X, Yang HC, Xu XF, Fang YR, Tan QR, Li HC, Wang G, Zhang L. Clinicodemographic correlates of psychotic features in bipolar disorder - a multicenter study in China. BMC Psychiatry. 2023 May 24;23(1):365. doi: 10.1186/s12888-023-04761-5.'}, {'pmid': '27825780', 'type': 'DERIVED', 'citation': 'Zhang L, Yang HC, Xu XF, Fang YR, Yu X, Tan QR, Li HC, Ungvari GS, Ng CH, Wang G, Xiang YT. Demographic and clinical differences between early- and late-onset bipolar disorders in a multicenter study in China. Psychiatry Res. 2016 Dec 30;246:688-691. doi: 10.1016/j.psychres.2016.10.063. Epub 2016 Oct 30.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=907&filename=NIS-NCN-XXX-2012_1-Bipolar%20Disorder%20in%20China_NISR_20151126-CSR%20SYNOPSIS.pdf', 'label': 'NIS-NCN-XXX-2012\\_1-Bipolar Disorder in China\\_NISR\\_20151126 CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objective of the ambispective cohort study is to describe clinical management and clinical outcomes related to bipolar disorder in China, and establish the factors associated with different management patterns and clinical outcomes, provide psychiatrists with reliable and up-to-date information on the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with bipolar disorder I or II with at least one mood event during the 3 and 12 months prior to the beginning of the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of subject informed consent.\n* Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder.\n* Patients who had at least one mood event( depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 3 and 12 months prior to the beginning of the study.\n\nExclusion Criteria:\n\n* Inability to complete Patient Reported Outcomes (PROs) questionnaires.\n* Participation in an interventional clinical study in last 12 months.'}, 'identificationModule': {'nctId': 'NCT01770704', 'briefTitle': 'Observation Study of the Clinical Management of Bipolar Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Chinese Observation Study of the Clinical Management of Bipolar Disorder', 'orgStudyIdInfo': {'id': 'NIS-NCN-XXX-2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed with bipolar disorder I or II'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Reserach Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Research SIte', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yu Xin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing No.6 Hospital'}, {'name': 'Wang Gang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}