Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-04-04 @ 11:27 PM
Study NCT ID:
NCT00178061
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2002-08'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression (HRSD-25)'}], 'secondaryOutcomes': [{'measure': 'Raskin Severity of Depression and Mania Scales'}]}, 'conditionsModule': {'conditions': ['Bipolar I Disorder', 'Borderline Personality Disorder']}, 'descriptionModule': {'briefSummary': 'This study will examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder.', 'detailedDescription': 'The major aim of this proposal is to examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder.\n\nThe specific aims are to create a research and supervisory team and to identify potential moderators of treatment response and mediators of outcome over the course of treatment.\n\nMembers of the team will meet weekly to begin a treatment development process for enhancing Interpersonal Social Rhythm Therapy (IPSRT) for these patients. Additional assessment measures will be utilized to examine the proposed mediators and moderators of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar I Disorder with Comorbid Borderline Personality Disorder, currently manic or depressed\n\nExclusion Criteria:\n\n* Unstable Medical illness'}, 'identificationModule': {'nctId': 'NCT00178061', 'briefTitle': 'Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Treatment of Primary Mood Disorders in the Comorbidly Ill', 'orgStudyIdInfo': {'id': '970843-0109'}, 'secondaryIdInfos': [{'id': '970843-0109'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Interpersonal Social Rhythm Therapy (IPSRT)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Ellen Frank', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}}}}