Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT00318669
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2006-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Social Anxiety Disorder Study Of Paroxetine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-31', 'releaseDate': '2017-06-08'}, {'releaseDate': '2017-11-08', 'unreleaseDate': '2018-08-15'}, {'releaseDate': '2018-08-27', 'unreleaseDate': '2018-08-30'}, {'resetDate': '2019-01-31', 'releaseDate': '2018-08-30'}], 'estimatedResultsFirstSubmitDate': '2017-06-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2006-04-25', 'studyFirstSubmitQcDate': '2006-04-25', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0)', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients responding with a CGI Global Improvement Item score. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment.', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anxiety', 'SAD', 'Social', 'Disorder'], 'conditions': ['Social Phobia']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.\n* Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.\n* Patients have a minimum score of 60 on the LSAS total score.\n\nExclusion criteria:\n\n* Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24weeks before week -2.\n* Patients with a history or complication of schizophrenia and bipolar disorder\n* Patients with a complication of body dysmorphic disorder.\n* Patients with evidence of substance abuse (alcohol or drugs)\n* substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.\n* Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.\n* Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.\n* Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.\n* Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.\n* Patients with a history or complication of cancer or malignant tumor.\n* Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.'}, 'identificationModule': {'nctId': 'NCT00318669', 'briefTitle': 'Social Anxiety Disorder Study Of Paroxetine', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Double-blind, Placebo-controlled Study- <Phase III Study>', 'orgStudyIdInfo': {'id': 'PIR104776'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paroxetine hydrochloride hydrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '802-0006', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '810-0001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '815-0041', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '332-0012', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '107-0062', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '120-0033', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '143-8541', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '144-0052', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '152-0012', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '154-0004', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '170-0002', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '170-0005', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '178-0063', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '194-0022', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-06-08', 'type': 'RELEASE'}, {'date': '2017-10-31', 'type': 'RESET'}, {'date': '2017-11-08', 'type': 'RELEASE'}, {'date': '2018-08-15', 'type': 'UNRELEASE'}, {'date': '2018-08-27', 'type': 'RELEASE'}, {'date': '2018-08-30', 'type': 'UNRELEASE'}, {'date': '2018-08-30', 'type': 'RELEASE'}, {'date': '2019-01-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'GlaxoSmithKline'}}}}