Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00358969
Status:
UNKNOWN
Last Update Posted:
2006-08-01
First Post:
2006-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Guanfacine to Treat Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016316', 'term': 'Guanfacine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2006-07-31', 'studyFirstSubmitDate': '2006-07-31', 'studyFirstSubmitQcDate': '2006-07-31', 'lastUpdatePostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measures of impulsive aggression'}, {'measure': 'measures of affective disturbance'}, {'measure': 'measures of social and occupational functioning'}, {'measure': 'measures of overall clinical status'}]}, 'conditionsModule': {'keywords': ['borderline personality disorder', 'guanfacine', 'impulsivity', 'aggression', 'affective instability'], 'conditions': ['Borderline Personality Disorder']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate whether guanfacine (Tenex) is an effective treatment for borderline personality disorder (BPD), an illness often characterized by unstable mood and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. We believe that guanfacine may improve symptoms of BPD by improving attention and aiding regulation of behavior.', 'detailedDescription': 'This is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (BPD). Prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional MRI scan, and complete a set of cognitive tests. While taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. At the end of the 8-week trial, participants will be asked to repeat the MRI scan and cognitive tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: This study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression.\n\nExclusion Criteria: Subjects must not currently be taking any psychiatric medications. Subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders.'}, 'identificationModule': {'nctId': 'NCT00358969', 'briefTitle': 'Guanfacine to Treat Borderline Personality Disorder', 'organization': {'class': 'FED', 'fullName': 'Bronx VA Medical Center'}, 'officialTitle': 'Guanfacine in the Treatment of Borderline Personality Disorder', 'orgStudyIdInfo': {'id': 'GCO 06-0518'}}, 'armsInterventionsModule': {'interventions': [{'name': 'guanfacine (Tenex)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Hospital - Mood & Personality Research Group', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Emily Hart', 'role': 'CONTACT', 'email': 'mpgroup@mssm.edu', 'phone': '(212) 241-4459'}, {'name': 'David Meyerson', 'role': 'CONTACT', 'email': 'david.meyerson@mssm.edu', 'phone': '(212) 241-9734'}], 'overallOfficials': [{'name': 'Antonia S. New, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}}}}