Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-29 @ 6:47 AM
Study NCT ID:
NCT01371461
Status:
COMPLETED
Last Update Posted:
2017-06-08
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice', 'timeFrame': '12 weeks'}, {'measure': 'Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II)', 'timeFrame': '12 weeks', 'description': "The investigator asked the patient to fill out a set of self-administered BDI-II forms at each time of the patient's visits to the medical center (Patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL)."}, {'measure': 'Efficacy evaluation based on overall improvement', 'timeFrame': '12 weeks', 'description': "The investigator comprehensively assessed the general condition of the patient at each time of the patient's visits to the medical center and rated the condition on a seven-grade eight-category scale (7 grades of markedly improved, moderately improved, slightly improved, unchanged, slightly worsened, worsened and severely worsened; a category of unassessable)."}, {'measure': 'Efficacy evaluation based on severities of specific symptoms', 'timeFrame': '12 weeks', 'description': "The investigator rated the severities of depressed mood, anxiety, feeling irritated, hypobulia, physical symptoms and sleep disorder on a four-grade scale (none, mild, moderate and severe) based on the interview and the results of BDI-II at each time of the patient's visits to the medical center (patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mental Disorders']}, 'descriptionModule': {'briefSummary': 'Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects of 18 years or more diagnosed with depression or in a depressed state, who are considered appropriate to prescribe paroxetine tablet according to the prescribing information', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who is 18 years or more\n* Subjects diagnosed with depression or in a depressed state\n\nExclusion Criteria:\n\n* Subjects who have been treated with paroxetine prior to this investigation\n* Subjects with hypersensitivity to paroxetine\n* Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs\n* Concomitant use in subjects taking pimozide'}, 'identificationModule': {'nctId': 'NCT01371461', 'briefTitle': 'Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)', 'orgStudyIdInfo': {'id': '112304'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients prescribed PAXIL', 'description': 'Patients with depression or depressed state prescribed PAXIL during study period', 'interventionNames': ['Drug: Paroxetine']}], 'interventions': [{'name': 'Paroxetine', 'type': 'DRUG', 'armGroupLabels': ['Patients prescribed PAXIL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}