Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-04 @ 7:32 AM
Study NCT ID:
NCT00511628
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2007-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1717}}, 'statusModule': {'whyStopped': 'Due to the achievement of minimum required sample size and new changes in local regulations.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2007-08-02', 'studyFirstSubmitQcDate': '2007-08-02', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Evaluation of Risperidone in patients who are overweight and/or obese', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Risperidone', 'Schizoaffective disorder', 'Schizophreniform disorder', 'Weight gain'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=284&filename=CR009313_CSR.pdf', 'label': 'Study on the safety of risperidone on obese or overweight patients with schizophrenia.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.', 'detailedDescription': 'This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) \\>25, or for patients that have increased their body weight \\>7% in the last year with the previous treatment (even with a BMI\\< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I \\& II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI \\>25; Patients have increased their body weight \\>7% in the last year with the previous treatment even with a BMI\\< 25 ; Patients that have shown intolerance to a previous antipsychotic treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI \\>25\n* Patients have increased their body weight \\>7% in the last year with the previous treatment even with a BMI\\< 25\n* Patients that have shown intolerance to a previous antipsychotic treatment\n\nExclusion Criteria:\n\n* Pregnant or lactating patients\n* Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder\n* Patients with neurology pathology except Parkinsonism induced by neuroleptics\n* Patients with other severe concomitant pathology\n* Patients treated with Risperidone in the last 30 days.'}, 'identificationModule': {'nctId': 'NCT00511628', 'briefTitle': 'Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag, S.A.'}, 'officialTitle': 'BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index', 'orgStudyIdInfo': {'id': 'CR009313'}}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'description': 'Risperidone As prescribed', 'interventionNames': ['Drug: Risperidone']}], 'interventions': [{'name': 'Risperidone', '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'}}}}