Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-29 @ 3:39 AM
Study NCT ID:
NCT00399334
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2006-11-10', 'studyFirstSubmitQcDate': '2006-11-10', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain', 'timeFrame': 'All data is collected in just one visit (i.e. cross-sectional and retrospective data)'}], 'secondaryOutcomes': [{'measure': 'Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient.', 'timeFrame': '1 visit (cross-sectional study)'}]}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizoaffective', 'relapse', 'risk factors', 'Observational study', 'Antipsychotic medication'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=285&filename=CR010609_CSR.pdf', 'label': 'Epidemiological study to analyze the clinical profile of patients with schizophrenia in short-stay psychiatric hospitalization units'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain.', 'detailedDescription': "Long-term treatment in schizophrenia begins in acute hospitalization. However inadequate treatment options in non-compliant patients discharged from acute inpatient settings are often leading to recidivism and frequent re-hospitalization. The objective of this epidemiologic survey is to evaluate epidemiological characteristics of relapse and readmission in acute psychiatric units. If long-term treatment in schizophrenia begins in acute hospitalization the use of the new long-acting injectable antipsychotics after an acute psychotic episode as a standard maintenance medication could prevent relapse and readmissions. This is a pharmaco-epidemiological study, which collects structured safety data and it is carried out in Spain. All data collected will be cross-sectional or retrospective and will include the following: demographic data, diagnosis, psychiatric history and co-morbidities, hospitalization record (previous 3 years), treatment record and physician's opinion on patient's treatment compliance. The primary objectives are to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain, to determine the most important risk factors which predicts the number of hospital re-admissions and to identify the impact of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses. The second objective is to describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. as prescribed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Schizophrenia or Schizoaffective disorder with a diagnosis over 2 years that are hospitalized in a Short-Term Psychiatric Hospitalization Unit or Acute Unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Schizophrenia or Schizoaffective disorder with a diagnosis over 2 years and that are hospitalized in a Short-Term Psychiatric Hospitalization Unit or Acute Unit\n\nExclusion Criteria:\n\n* Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder\n* Patients with Schizophrenia or Schizoaffective disorder with a diagnosis less than 2 years'}, 'identificationModule': {'nctId': 'NCT00399334', 'briefTitle': 'PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag, S.A.'}, 'officialTitle': 'Study PROFILe3: Clinic Observations Profile of Relapse and Readmission in Emergency/Acute Settings: Epidemiologic Survey in Schizophrenic Patients', 'orgStudyIdInfo': {'id': 'CR010609'}}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'interventionNames': ['Drug: antipsychotic medications']}], 'interventions': [{'name': 'antipsychotic medications', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag, S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Country Medical Director', 'oldOrganization': 'Janssen-Cilag S.A., Spain'}}}}