Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT00287820
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2006-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum glucose', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'Hb1AC', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'triglycerides', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'cholesterol', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'insulin', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'c-peptide', 'timeFrame': 'during 5 months of treatment compared to baseline'}], 'secondaryOutcomes': [{'measure': 'ghrelin', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'CRP', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'Thyroid hormones', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'prolactin', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'Il-6', 'timeFrame': 'during 5 months treatment compared to baseline'}, {'measure': 'PANSS scores', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'CGI score', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'EPS scores', 'timeFrame': 'during 5 months of treatment compared to baseline'}, {'measure': 'TD Scores', 'timeFrame': 'during 5 months of treatment compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'diabetes', 'metabolic syndrome', 'hyperglycemia', 'glucose', 'insulin', 'lipids', 'IL-6', 'prolactin'], 'conditions': ['Schizophrenia', 'Diabetes', 'Metabolic Syndrome', 'Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '22475524', 'type': 'DERIVED', 'citation': 'Smith RC, Rachakonda S, Dwivedi S, Davis JM. Olanzapine and risperidone effects on appetite and ghrelin in chronic schizophrenic patients. Psychiatry Res. 2012 Oct 30;199(3):159-63. doi: 10.1016/j.psychres.2012.03.011. Epub 2012 Apr 3.'}, {'pmid': '20457512', 'type': 'DERIVED', 'citation': 'Smith RC, Lindenmayer JP, Hu Q, Kelly E, Viviano TF, Cornwell J, Vaidhyanathaswamy S, Marcovina S, Davis JM. Effects of olanzapine and risperidone on lipid metabolism in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized five month study. Schizophr Res. 2010 Jul;120(1-3):204-9. doi: 10.1016/j.schres.2010.04.001. Epub 2010 May 10.'}, {'pmid': '19814947', 'type': 'DERIVED', 'citation': 'Smith RC, Lindenmayer JP, Davis JM, Kelly E, Viviano TF, Cornwell J, Hu Q, Khan A, Vaidhyanathaswamy S. Effects of olanzapine and risperidone on glucose metabolism and insulin sensitivity in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized 5-month study. J Clin Psychiatry. 2009 Nov;70(11):1501-13. doi: 10.4088/JCP.08m04446yel. Epub 2009 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism.\n\nWe hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.', 'detailedDescription': 'In the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. In addition to the biochemical measures, we will also assess clinical effects (PANSS and CGI ratings) and other side-effects (weight gain, appetite, somnolence, and EPS and TD). The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone.\n\nAdditional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and CRP and IL-6, and thyroid and prolactin response to five months of treatment with the two drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis\n* Schizophrenia or schizoaffective psychosis\n* 18-65 years of age\n\nExclusion Criteria:\n\n* Currently being treated with oral antidiabetics or insulin'}, 'identificationModule': {'nctId': 'NCT00287820', 'briefTitle': 'Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Nathan Kline Institute for Psychiatric Research'}, 'officialTitle': 'Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism', 'orgStudyIdInfo': {'id': 'FiD-MC-x226(7524)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'olanzapine', 'interventionNames': ['Drug: Olanzapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'risperidone', 'interventionNames': ['Drug: risperidone']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['ayprexa'], 'description': 'olanzapine 5-40 mg/day', 'armGroupLabels': ['1']}, {'name': 'olanzapine', 'type': 'DRUG', 'otherNames': ['zyprexa'], 'description': 'olanzapine 5-40 ,mg/day', 'armGroupLabels': ['1']}, {'name': 'risperidone', 'type': 'DRUG', 'otherNames': ['riperidal'], 'description': 'risperidone 1-12 mg/day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10035', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Psychaitric Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert C Smith, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Robert C. Smith MD', 'oldOrganization': 'Manhatan Psychiatric Center'}}}}