Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT01454635
Status:
COMPLETED
Last Update Posted:
2011-10-31
First Post:
2011-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2011-11-27', 'unreleaseDateUnknown': True}, {'resetDate': '2012-07-10', 'releaseDate': '2012-06-07'}], 'estimatedResultsFirstSubmitDate': '2011-11-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-27', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'treatment response', 'selective serotonin reuptake inhibitor'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.', 'detailedDescription': 'While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of Major Depressive Disorder\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* pregnant\n* breastfeeding'}, 'identificationModule': {'nctId': 'NCT01454635', 'acronym': 'AFADTRMDD', 'briefTitle': 'Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Showa University'}, 'officialTitle': 'Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'SU-GEC-84'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sertraline, Treatment response', 'description': 'dosage, frequency and duration', 'interventionNames': ['Drug: Sertraline']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['J Zoloft®'], 'description': 'dosage,frequency and duration', 'armGroupLabels': ['Sertraline, Treatment response']}]}, 'contactsLocationsModule': {'locations': [{'zip': '224-8503', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Showa University Northern Yokohama Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Yuji Kiuchi, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Showa University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Showa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tokyo Metropolitan Police Hospital, Department of Psychiatry, Principal Investigator', 'investigatorFullName': 'Gentaro Nishioka', 'investigatorAffiliation': 'Showa University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-11-27', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2012-06-07', 'type': 'RELEASE'}, {'date': '2012-07-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gentaro Nishioka, Tokyo Metropolitan Police Hospital, Department of Psychiatry, Principal Investigator, Showa University'}}}}