Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT00458367
Status:
COMPLETED
Last Update Posted:
2010-10-18
First Post:
2007-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RiSPECT: Risperdal Safety Protocol Evaluation Consta Treatment, a Post Authorization Safety Survey to Obtain Information on the Safety and Efficacy of Risperidone When Used in Routine Clinical Practice
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-15', 'studyFirstSubmitDate': '2007-04-06', 'studyFirstSubmitQcDate': '2007-04-06', 'lastUpdatePostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To confirm safety, as identified in phase III clinical trials of risperidone by collecting data (including adverse event information) when the drug is used under marketed conditions in routine clinical practice.', 'timeFrame': 'at baseline and at month 1, 3 and 6.'}], 'secondaryOutcomes': [{'measure': 'To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)', 'timeFrame': 'Baseline and at month 1, 3 and 6'}, {'measure': 'To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)', 'timeFrame': 'Baseline and at month 1, 3 and 6'}]}, 'conditionsModule': {'keywords': ['PASS', 'Safety Assessment', 'Efficacy Assessment', 'long-acting injectable risperidone'], 'conditions': ['Schizophrenia', 'Psychotic Disorders', 'Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.', 'detailedDescription': 'This post-authorisation safety survey (PASS) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. This is a single-arm, prospective, observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. The study duration is 6 months with 4 patient visits. The primary objective of this PASS is to confirm safety, as identified in phase III clinical trials of risperidone, by collecting data when the drug is used under marketed conditions in routine clinical practice. A secondary objective is to evaluate effectiveness and reasons for initiating risperidone. Each investigator is to document data for 4-10 treated patients for whom risperidone long-acting injectable (RLAI) treatment is determined to be clinically indicated. Risperidone long-acting injectable (RLAI) is given as intramuscular injections every 2 weeks. The starting dose of RLAI will be in accordance with the product label (usually 25 mg). If necessary, the dosage of the injection may be increased gradually. Treatment duration is 26 weeks. To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local SmPC, are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local Summary of Product Characteristics (SmPC), are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder\n\nExclusion Criteria:\n\n* According to the SmPC, long-acting injectable risperidone is contraindicated in patients with a known hypersensitivity to the product or any of its components. These patients must be excluded from the survey'}, 'identificationModule': {'nctId': 'NCT00458367', 'briefTitle': 'RiSPECT: Risperdal Safety Protocol Evaluation Consta Treatment, a Post Authorization Safety Survey to Obtain Information on the Safety and Efficacy of Risperidone When Used in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutica N.V., Belgium'}, 'officialTitle': 'Risperdal Safety Protocol Evaluation Consta Treatment; A Post Authorization Safety Survey With RISPERDAL CONSTA TM', 'orgStudyIdInfo': {'id': 'CR003373'}}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'description': 'Open label risperidone long acting injectable intramuscular injections every 2 weeks for 26 weeks flexible dose 25 to 50 mg', 'interventionNames': ['Drug: Open label risperidone long acting injectable']}], 'interventions': [{'name': 'Open label risperidone long acting injectable', 'type': 'DRUG', 'description': 'intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Pharmaceutica N.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutica N.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutica N.V., Belgium', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'European Medical Affairs Director, Psychiatry', 'oldOrganization': 'Janssen-Cilag S.A., Spain'}}}}