Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-21 @ 3:22 PM
Study NCT ID:
NCT00633802
Status:
UNKNOWN
Last Update Posted:
2008-03-12
First Post:
2008-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-11', 'studyFirstSubmitDate': '2008-03-04', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Improvement Scale', 'timeFrame': '0, 1, 5, 10 week'}]}, 'conditionsModule': {'keywords': ['Risperidone', 'Borderlone Personality Disorder'], 'conditions': ['Borderlone Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '36375174', 'type': 'DERIVED', 'citation': 'Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.'}]}, 'descriptionModule': {'briefSummary': "Personality disorders are life-long maladaptive behavioral patterns. Borderline personality disorder (BPD) is the leading personality disorder encountered in clinical settings, often associated with tremendous distress. It is characterized by impulsivity, emotional lability, unstable interpersonal relationships, with particular sensitivity to abandonment. BPD patients are prone to self destructive behaviors and all too frequently attempt suicide. When in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.\n\nPsychotherapy for BPD is a common treatment option, but it requires considerable time and specific personnel training, and is therefore not always feasible. Medical treatment is an efficacious alternative, however there is no concensus on drug selection. Some experts have suggested that medical treatment should be selected individually according to the subject's dominant clinical symptom. Several psychopharmacological groups have been proposed: Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are particularly promising since they may produce symptomaic improvement with fewer adverse effects. Risperidone has been shown in a few preliminary studies to be promising in the treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design using both clinical and phsysiological measure.The main hypothesis is that risperidone will be efficient in alleviating BPD core and secondary symptoms."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women with Borderline PD according to DSM-IV\n2. Signed informed consent.\n3. Age 18-45.\n\nExclusion Criteria:\n\n1. Psychotic disorders (past or present).\n2. Substance or alcohol related disorders (past or present).\n3. Current major depressive episode.\n4. Suicidal risk.\n5. History of head trauma, which caused loss of consciousness or peritraumatic amnesia or necessitated hospitalization.\n6. Any known psychiatric or general medical condition currently requiring specific medical attention.\n7. Current treatment with any antipsychotic, antidepressant drugs or mood stabilizers.'}, 'identificationModule': {'nctId': 'NCT00633802', 'briefTitle': 'Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'orgStudyIdInfo': {'id': '04-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Risperidone']}, {'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Risperidone']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'description': '1 mg/d risperidone for 10 weeks or placebo', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Miki Bloch, Ph.D.', 'role': 'CONTACT', 'phone': '972-3-6974568'}, {'name': 'Miki Bloch, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychiatric Service, Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Miki Bloch, Ph.D.', 'role': 'CONTACT', 'email': 'mikib@tasmc.health.gov.il', 'phone': '972-3-6974568'}], 'overallOfficials': [{'name': 'Miki Bloch, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Miki Bloch', 'oldOrganization': 'Tel-Aviv Sourasky Medical Center'}}}}