Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-27 @ 9:30 AM
Study NCT ID:
NCT00215150
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Geodon for the Treatment of Refractory Social Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092292', 'term': 'ziprasidone'}, {'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wei.zhang@duke.edu', 'phone': '(919) 684 5645', 'title': 'Wei Zhang, MD', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open Label Phase', 'description': 'The first 8 weeks of treatment on sertraline', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Randomization Phase for Ziprasidone', 'description': 'The second phase of treatment with subjects randomized to ziprasidone augmentation.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Randomization Phase for Placebo', 'description': 'The second phase of treatment with subjects randomized to placebo augmentation.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brief Social Phobia Scale(BSPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Phase', 'description': 'The open label treatment phase for the first 8 weeks'}, {'id': 'OG001', 'title': 'Randomization Phase for Ziprasidone Group', 'description': 'The group of subjects randomized to receive Ziprasidone for the second 8 weeks'}, {'id': 'OG002', 'title': 'Randomization Phase for Placebo Group', 'description': 'The group of subjects randomized to receive placebo for the second 8 weeks'}], 'classes': [{'title': 'Beginning of Study Phase', 'categories': [{'measurements': [{'value': '44.0', 'spread': '11.1', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '67'}, {'value': '31.8', 'spread': '8.9', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '47'}, {'value': '31.8', 'spread': '11.8', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '55'}]}]}, {'title': 'End of Study Phase', 'categories': [{'measurements': [{'value': '31.2', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '24.6', 'spread': '12.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 and 16 weeks', 'description': 'An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label Treatment', 'description': '8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.'}], 'periods': [{'title': 'Open Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of subjects consented', 'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Did not complete a post base visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Did not meet randomization criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}, {'title': 'Randomization Phase Ziprasidone', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Randomization Phase Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Treatment', 'description': '8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This is the intent to treat population consisting of subjects completing at least one post baseline visit.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2005-09-20', 'resultsFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-16', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Social Phobia Scale(BSPS)', 'timeFrame': 'Baseline, 8 and 16 weeks', 'description': 'An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anxiety disorder', 'SAD', 'ziprasidone', 'sertraline', 'antidepressant', 'antipsychotic'], 'conditions': ['Social Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '1757457', 'type': 'BACKGROUND', 'citation': 'Davidson JR, Potts NL, Richichi EA, Ford SM, Krishnan KR, Smith RD, Wilson W. The Brief Social Phobia Scale. J Clin Psychiatry. 1991 Nov;52 Suppl:48-51. doi: 10.1037/t07672-000.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone', 'detailedDescription': 'This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults 18-65 years of age\n* primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria\n* minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline\n* minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline\n* written informed consent\n* negative serum pregnancy test for women of childbearing potential\n* normal EKG\n\nExclusion Criteria:\n\n* current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition\n* any current primary anxiety disorder other than SAD\n* current primary depression\n* history of substance abuse or dependence within the last 3 months\n* suicide risk or serious suicide attempt within the last year\n* clinically significant medical condition or laboratory or EKG abnormality\n* women of childbearing potential who are unwilling to practice an acceptable method of contraception\n* patients needing concurrent use of psychotropic medications\n* history of hypersensitivity to sertraline or ziprasidone\n* recent (less than 2 months) initiation of psychotherapy for SAD\n* history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic\n* patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra'}, 'identificationModule': {'nctId': 'NCT00215150', 'acronym': 'SAD', 'briefTitle': 'Geodon for the Treatment of Refractory Social Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Ziprasidone for the Treatment of Refractory Social Anxiety Disorder', 'orgStudyIdInfo': {'id': 'Pro00012882'}, 'secondaryIdInfos': [{'id': '6479', 'type': 'OTHER', 'domain': 'Duke legacy protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open Label Treatment', 'description': '8 weeks of open label treatment with sertraline', 'interventionNames': ['Drug: Sertraline']}, {'type': 'OTHER', 'label': 'Randomization Ziprasidone', 'description': '8 weeks of treatment with sertraline augmented with ziprasidone', 'interventionNames': ['Drug: Ziprasidone', 'Drug: Sertraline']}, {'type': 'OTHER', 'label': 'Randomization Placebo', 'description': '8 weeks of treatment with sertraline augmented by placebo', 'interventionNames': ['Drug: Sertraline']}], 'interventions': [{'name': 'Ziprasidone', 'type': 'DRUG', 'otherNames': ['Geodon'], 'description': 'Sertraline augmentation with ziprasidone', 'armGroupLabels': ['Randomization Ziprasidone']}, {'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': 'Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase', 'armGroupLabels': ['Open Label Treatment', 'Randomization Placebo', 'Randomization Ziprasidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Wei Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}