Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-03 @ 1:34 PM
Study NCT ID:
NCT02760693
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolar Cohort Neunkirchen, Final Statement
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 515}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-29', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relapses, hospital admissions, number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': 'patients from the cohort are contacted once a year (1 to 6 years)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bipolar disorder, naturalistic cohort study,', 'defined catchment area,long term treatment'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '25240845', 'type': 'BACKGROUND', 'citation': 'Simhandl C, Radua J, Konig B, Amann BL. The prevalence and effect of life events in 222 bipolar I and II patients: a prospective, naturalistic 4 year follow-up study. J Affect Disord. 2015 Jan 1;170:166-71. doi: 10.1016/j.jad.2014.08.043. Epub 2014 Sep 6.'}, {'pmid': '25972409', 'type': 'BACKGROUND', 'citation': 'Simhandl C, Radua J, Konig B, Amann BL. Prevalence and impact of comorbid alcohol use disorder in bipolar disorder: A prospective follow-up study. Aust N Z J Psychiatry. 2016 Apr;50(4):345-51. doi: 10.1177/0004867415585855. Epub 2015 May 13.'}, {'pmid': '24717379', 'type': 'RESULT', 'citation': 'Simhandl C, Konig B, Amann BL. A prospective 4-year naturalistic follow-up of treatment and outcome of 300 bipolar I and II patients. J Clin Psychiatry. 2014 Mar;75(3):254-62; quiz 263. doi: 10.4088/JCP.13m08601.'}]}, 'descriptionModule': {'briefSummary': 'monitoring system and data base for long term follow up of various treatment strategies in a naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design, prospective \\& retrospective', 'detailedDescription': 'all hospitalized patients of a defined mixed urban and more rural area were consecutively interviewed at admission and entered into the data base. at discharge they gave written informed consent for further tracking and interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community of wiener neustadt and neunkirchen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bipolar\n\nExclusion Criteria:\n\n* all other diagnoses'}, 'identificationModule': {'nctId': 'NCT02760693', 'briefTitle': 'Bipolar Cohort Neunkirchen, Final Statement', 'nctIdAliases': ['NCT01792128'], 'organization': {'class': 'OTHER', 'fullName': 'Österreichische Gesellschaft für Bipolare Erkrankungen'}, 'officialTitle': 'SPICS (Secure Platform for Integrating Clinical Studies) for Recurrent (Bipolar) Affective Disorders for Long Term Follow up Treatment Regiments and Outcome in a Natural Setting', 'orgStudyIdInfo': {'id': 'Protocoll2'}, 'secondaryIdInfos': [{'id': 'SPICS2010-2', 'type': 'OTHER', 'domain': 'Österreichische Gesellschaft für Bipolare Erkrankungen'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'bipolar patients', 'description': 'unselected admissions of bipolar patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'BIPOLAR Zentrum Wiener Neustadt', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}], 'overallOfficials': [{'name': 'Christian A. Simhandl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bipolar Zentrum WN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Österreichische Gesellschaft für Bipolare Erkrankungen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}