Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT01992302
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
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': 289}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who develop rapid cycling', 'timeFrame': '8 years'}], 'secondaryOutcomes': [{'measure': 'Factors associated with the development of a rapid cycling course in bipolar disorder patients', 'timeFrame': '8 years'}]}, 'conditionsModule': {'keywords': ['Rapid cycling'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'In this study we tried to elucidate the factors associated with the development of a rapid cycling course in bipolar disorder patients, in a prospective and longitudinal design, and the role of antidepressants. The identification of risk factors is extremely relevant from the clinical point of view. We hypothesized that rapid cycling bipolar disorder is associated with more chronicity, poor outcome, and more antidepressant prescription.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bipolar I and II disorder patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar I and II disorder patients according to DSM-IV criteria\n\nExclusion Criteria:\n\n* Major medical comorbidities, voluntary drop-out from study'}, 'identificationModule': {'nctId': 'NCT01992302', 'briefTitle': 'Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients', 'orgStudyIdInfo': {'id': 'RC-BBP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rapid Cycling Group', 'description': 'Patients who develop a rapid cycling course during the follow-up period.'}, {'label': 'Non Rapid Cycling Group', 'description': 'Patients who do not develop a rapid cycling course during the follow-up period.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08037', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Marc Valenti', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}