Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 11:53 PM
Study NCT ID:
NCT00999895
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 574}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CGI-CB scale score of subjects achieving a score of < 4.', 'timeFrame': 'At Week 18 - once'}], 'secondaryOutcomes': [{'measure': 'Change in PANSS scale', 'timeFrame': 'Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks'}, {'measure': 'Change in BARS scale', 'timeFrame': 'Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks'}, {'measure': 'Changes in CGI-S and CGI-I scales', 'timeFrame': 'Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Switch of antipsychotic treatment', 'Outcome evaluation', 'monotherapy', 'Greece'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '24359635', 'type': 'DERIVED', 'citation': 'Roussidis A, Kalkavoura C, Dimelis D, Theodorou A, Ioannidou I, Mellos E, Mylonaki T, Spyropoulou A, Yfantis A. Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study. Ann Gen Psychiatry. 2013 Dec 20;12(1):42. doi: 10.1186/1744-859X-12-42.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the outcome of treatment switch defined as an improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have undergone a switch in their antipsychotic treatment and fulfill the following criteria will participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia (as per DSM-IV), at least 6 months prior to enrolment in the study\n* Subjects who have initiated a new antipsychotic treatment within the preceding 2 weeks\n* Subjects whose prior and current antipsychotic treatment consists of any typical or atypical antipsychotic monotherapy\n\nExclusion Criteria:\n\n* Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from schizophrenia), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation\n* Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria and not in full remission\n* Female subjects who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00999895', 'acronym': 'ETOS', 'briefTitle': 'A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non-interventional, Prospective, Open-label Study for the Evaluation of the Selection and Outcome of the Antipsychotic Treatment Switch in Outpatients With Schizophrenia - ETOS Study', 'orgStudyIdInfo': {'id': 'NIS-NGR-DUM-2009/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antipsychotic outpatients with schizophrenia', 'description': 'Switched treatment of antipsychotic outpatients with schizophrenia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pátrai', 'state': 'Achaias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Nafplion', 'state': 'Argolidas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.56863, 'lon': 22.80691}}, {'city': 'Tripoli', 'state': 'Arkadias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.50959, 'lon': 22.37883}}, {'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Dafni', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.95002, 'lon': 23.73437}}, {'city': 'Drapetsona', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94988, 'lon': 23.62309}}, {'city': 'Exarcheia', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98662, 'lon': 23.73509}}, {'city': 'Glifada', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Ilioúpoli', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.93149, 'lon': 23.76779}}, {'city': 'Ilissia', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Koridalos', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Marousi', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'city': 'N. Makri', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'P. Faliro', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Pangrati', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.97113, 'lon': 23.74751}}, {'city': 'Peristeri', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.01539, 'lon': 23.69187}}, {'city': 'Petroúpolis', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04187, 'lon': 23.68494}}, {'city': 'Piraeus', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Zografos', 'state': 'Attica', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.97574, 'lon': 23.76911}}, {'city': 'Athens', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Koropí', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89886, 'lon': 23.87181}}, {'city': 'Néo Irákleio', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04272, 'lon': 23.7673}}, {'city': 'Chania', 'state': 'Chanion', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 35.51124, 'lon': 24.02921}}, {'city': 'Kos', 'state': 'Dodekanissou', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 36.89295, 'lon': 27.28768}}, {'city': 'Corfu', 'state': 'Eptanisa', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.62441, 'lon': 19.92016}}, {'city': 'Agrinio', 'state': 'Etoloakarnanias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62139, 'lon': 21.40778}}, {'city': 'Alexandroupoli', 'state': 'Evrou', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Lamia', 'state': 'Fthiotidos', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89947, 'lon': 22.4335}}, {'city': 'Heraklio', 'state': 'Herakliou', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Véroia', 'state': 'Imatheias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.52437, 'lon': 22.20242}}, {'city': 'Ioannina', 'state': 'Ioanninon', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'city': 'Karditsa', 'state': 'Karditsas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.36485, 'lon': 21.92191}}, {'city': 'Kavala', 'state': 'Kavalas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'city': 'Larissa', 'state': 'Larissas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Volos', 'state': 'Magnisias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}, {'city': 'Kalamata', 'state': 'Mesinias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.03913, 'lon': 22.11265}}, {'city': 'Giannitsá', 'state': 'Pellas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79194, 'lon': 22.4075}}, {'city': 'Rethymno', 'state': 'Rethimnou', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 35.36555, 'lon': 24.48232}}, {'city': 'Komotini', 'state': 'Rodopis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 41.11758, 'lon': 25.40587}}, {'city': 'Serres', 'state': 'Serres', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}, {'city': 'Thessaloniki', 'state': 'Thessalonikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Trikala', 'state': 'Trikalon', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}, {'city': 'Thebes', 'state': 'Viotias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.325, 'lon': 23.31889}}], 'overallOfficials': [{'name': 'Panagiotis Pontikis, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}