Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-26 @ 11:46 PM
Study NCT ID:
NCT00520650
Status:
COMPLETED
Last Update Posted:
2009-12-16
First Post:
2007-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Evaluation of Abilify Long-term Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-15', 'studyFirstSubmitDate': '2007-08-23', 'studyFirstSubmitQcDate': '2007-08-23', 'lastUpdatePostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.', 'timeFrame': 'Throughout the study'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.', 'timeFrame': 'Throughout the study'}, {'measure': 'Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.', 'timeFrame': 'Throughout the study.'}, {'measure': 'Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.', 'timeFrame': 'Throughout the study.'}, {'measure': 'Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.', 'timeFrame': 'throughout the study'}, {'measure': 'Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.', 'timeFrame': 'Throughout the study.'}, {'measure': 'Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.', 'timeFrame': 'Throughout the study.'}, {'measure': 'CGI-I scores after 12, 26, 39, and 52 weeks of treatment.', 'timeFrame': 'Throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': "This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.", 'detailedDescription': 'Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients between the ages of 18 to 65.\n2. Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.\n3. Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding women or planning a pregnancy.\n2. Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.\n3. A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).\n4. Patient has clinically relevant organic, neurological, or cardiovascular diseases.\n5. Patient has a history of drug or alcohol abuse within the last 12 weeks.\n6. Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.\n7. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.\n8. Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.\n9. Depot neuroleptics should be discontinued at least 2 months prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT00520650', 'acronym': 'HEALTH', 'briefTitle': 'Health Evaluation of Abilify Long-term Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiwan Otsuka Pharm. Co., Ltd'}, 'officialTitle': 'Health Evaluation of Abilify Long-term Therapy', 'orgStudyIdInfo': {'id': '31-06-P01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Douliu', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Yun-Lin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'city': 'Hsinchu', 'country': 'Taiwan', 'facility': 'Cardinal Tien Hospital Hsin Chu Mercy Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}, {'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Buddhist Tzu Chi General Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'city': 'Miaoli', 'country': 'Taiwan', 'facility': 'Wei Gong Memorial Hospital', 'geoPoint': {'lat': 24.56427, 'lon': 120.82367}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cathay General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wei-Wen Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiwan Otsuka Pharm. Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Edward C.Y. Peng', 'oldOrganization': 'Taiwan Otsuka Pharm. Co., Ltd'}}}}