Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01342120
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2011-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PHARMO Institute Seroquel Safety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-31', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atypical antipsychotics', 'quetiapine'], 'conditions': ['Schizophrenia', 'Major Depressive Disorder', 'Bipolar Disorder', 'Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '27297785', 'type': 'DERIVED', 'citation': 'Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population based sample of about 2.5 millions residents in the Netherlands', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.\n\nExclusion Criteria:\n\n* less than a year of recorded history before the cohort entry date\n* use of multiple antipsychotics concomitantly\n* duration and dose of the antipsychotic drug cannot be determined'}, 'identificationModule': {'nctId': 'NCT01342120', 'acronym': 'PHARMO II', 'briefTitle': 'PHARMO Institute Seroquel Safety Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Seroquel Safety Study', 'orgStudyIdInfo': {'id': 'D1443L00085'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Quetiapine', 'description': 'Quetipine users'}, {'label': 'All other atypical antipsychotics', 'description': 'All other atypical antipsychotics users'}, {'label': 'Risperidone', 'description': 'Risperidone users'}, {'label': 'Olanzapine', 'description': 'Olanzapine users'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Edith Heintjes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PHARMO Institute for Drug Outcomes Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PHARMO Institute for Drug Outcomes Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}