Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 3:00 PM
Study NCT ID:
NCT00352768
Status:
TERMINATED
Last Update Posted:
2010-03-04
First Post:
2006-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016666', 'term': 'Fluvoxamine'}], 'ancestors': [{'id': 'D010091', 'term': 'Oximes'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'This study was prematurely terminated (26 June 2009) due to slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-03', 'studyFirstSubmitDate': '2006-07-14', 'studyFirstSubmitQcDate': '2006-07-14', 'lastUpdatePostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the time of onset of 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score", 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'The Clinical Global Impression(CGI) improvement at Week 10', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fluvoxamine Maleate', 'OCD', 'Children and Adolescents'], 'conditions': ['Obsessive Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Have a minimum total score of 16 on the JCY-BOCS, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate'}, 'identificationModule': {'nctId': 'NCT00352768', 'briefTitle': 'Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'SME3110 (Fluvoxamine Maleate) in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'S114.3.118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F', 'interventionNames': ['Drug: Fluvoxamine maleate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fluvoxamine maleate', 'type': 'DRUG', 'description': 'Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica', 'armGroupLabels': ['F']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['P']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiba Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Kohnodai Hospital, National Center of N'}, {'city': 'Fukuoka Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Kyushu University Hospital'}, {'city': 'Hiroshima Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Hiroshima-city Funairi Hospital'}, {'city': 'Hokkaido Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Goryokai Hospital'}, {'city': 'Hyogo Prefecture', 'country': 'Japan', 'facility': "S114.3.118 Hyogo Children's Hospital"}, {'city': 'Hyogo Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Kobe University Hospital'}, {'city': 'Kagawa Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 National Hospital Organization Kagawa C'}, {'city': 'Kumamoto Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 National Hospital Organization Kikuti N'}, {'city': 'Mie Prefecuture', 'country': 'Japan', 'facility': 'S114.3.118 National Hospital Organization Sakakiba'}, {'city': 'Nara Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Nara Medical University Hospital'}, {'city': 'Tokushima Prefecture', 'country': 'Japan', 'facility': 'S114.3.118 Tokushima University Hospital'}], 'overallOfficials': [{'name': 'Toshiaki Yamaguchi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}}}}