Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00692133
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2008-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-08', 'studyFirstSubmitDate': '2008-06-05', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TOOL questionnaire', 'timeFrame': '15 days'}, {'measure': 'PANSS & Young Mania Scale', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Montgomery Asberg Depression Scale', 'timeFrame': '15 days'}, {'measure': 'Euroqol 5D & SF-36D', 'timeFrame': 'performed only at baseline visit'}, {'measure': 'UKU modified scale', 'timeFrame': 'performed only at baseline visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'bipolar disorder', 'antipsychotic treatment', 'patients´preferences'], 'conditions': ['Schizophrenia', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia and bipolar disorder (DSM-IV criteria)\n* Stabilized out-patients\n* Treated with the same oral antipsychotic at least in the last month\n\nExclusion Criteria:\n\n* Participation in another clinical trial within 6 months prior to enrolment into this study\n* Administration of a depot antipsychotic medication'}, 'identificationModule': {'nctId': 'NCT00692133', 'acronym': 'TOOL', 'briefTitle': 'Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 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