Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT00231894
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2005-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'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': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rsmith@nki.rfmh.org', 'phone': '845-398-6531', 'title': 'Robert C. Smith MD', 'organization': 'Nathan Kline Institute ofr Psychiatric research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Sufficient RBANS data at baseline and 3 months followup for China sample was not available for analysis. Subjects failed to complete scales or complete scales with sufficient data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone', 'description': 'pioglitazone', 'otherNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo', 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'glucose increase', 'notes': "One subject had very high glucose values (376 fasting; 530 hour one GTT). It was determined the patient was on a placebo. There was a gap in the patient's insulin coverage..", 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'glucose increase', 'notes': 'Patient had high glucose levels and was determined to be on placebo arm of study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'high CPK', 'notes': 'Increased in CPK which was not attributable to the study medication (pioglitazone or placebo), but to another medication that the patient was on (gemfibrozil) which the patient had been prescribed previously by this clinical physician..', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'pioglitazone and life-style diet group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo and life-style diet group'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.65', 'spread': '24.01', 'groupId': 'OG000'}, {'value': '30.99', 'spread': '26.82', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pre-treatment and during 3 months of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of triglycerides at baseline and three months followup. See table 2 of published paper given in reference for further details.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Piogltiazone', 'description': 'pioglitazone and life-style diet group\n\nPioglitazone: pioglitazone 15-45 mg/day\n\nLife style diet group: life style diet education group 1x/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo and life-style diet group\n\nLife style diet group: life style diet education group 1x/week\n\nplacebo: placebo comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '4.62', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-2.59', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pre-treatment and during 3 months of treatment', 'description': 'serum high density lipoprotein (HDL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of HDL at baseline and three months followup. See table 2 of published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'pioglitazone'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '24.20', 'spread': '8.63', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pretreatment and during 3 months of drug treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'PRIMARY', 'title': '2 Hour Glucose From Glucose Tolerance Test US Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'pioglitazone and life-style diet group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo and life-style diet group'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.19', 'spread': '17.03', 'groupId': 'OG000'}, {'value': '15.19', 'spread': '17.75', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'between baseline and 3 months of study drug treatment', 'description': 'difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'SECONDARY', 'title': 'Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'pioglitazone'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pre-treatment and 3 months of treatment', 'description': 'The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measure cognitive function in patients with schizophrenia. Range for list learning sub-score is 0 to 20 . Higher values indicate better performance. For change score (3 months -baseline) positive values indicate improved performance for this cognitive function and negative values indicate poorer performance on this cognitive function.', 'unitOfMeasure': 'Units on RBANS scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at U.S. sites N=43, Pioglitazone =25, Placebo =18, who had scores of RBANS List learning at 2-hour point at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (30-45 mg/daily) plus life-style diet education group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules daily plus life-style diet education group'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.33', 'spread': '11.08', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '3.44', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pretreatment and during 3 months of drug treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of fasting glucose at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (30-45 mg/daily) plus life-style diet education group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules daily plus life-style diet education group'}], 'classes': [{'categories': [{'measurements': [{'value': '32.56', 'spread': '24.76', 'groupId': 'OG000'}, {'value': '-79.12', 'spread': '40.72', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pretreatment and during 3 months of drug treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of triglycerides at baseline and three months followup. See published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'SECONDARY', 'title': '2 Hour Glucose From Glucose Tolerance Test China Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (30-45 mg/daily) plus life-style diet education group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules daily plus life-style diet education group'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.82', 'spread': '21.28', 'groupId': 'OG000'}, {'value': '-40.72', 'spread': '21.28', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'between baseline and 3 months of study drug treatment', 'description': 'difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at china site N=10, Pioglitazone =5, Placebo =5, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (30-45 mg/daily) plus life-style diet education group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules daily plus life-style diet education group'}], 'classes': [{'categories': [{'measurements': [{'value': '6.52', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '7.72', 'spread': '3.37', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'pretreatment and during 3 months of drug treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is from participants at china. site N=10, Pioglitazone =5, Placebo =5, who had values of HDL at baseline and three months followup. See of published paper and its supplementary data paper cited in reference for further details'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (30-45 mg/daily) plus life-style diet education group'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo capsules daily plus life-style diet education group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment at 6 U.S. sites and one site in Shanghai, China'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone', 'description': 'pioglitazone'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '9.06', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '10.17', 'groupId': 'BG001'}, {'value': '47.7', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2005-10-03', 'resultsFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-09', 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample', 'timeFrame': 'pre-treatment and during 3 months of treatment'}, {'measure': 'Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample', 'timeFrame': 'pre-treatment and during 3 months of treatment', 'description': 'serum high density lipoprotein (HDL)'}, {'measure': 'Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample', 'timeFrame': 'pretreatment and during 3 months of drug treatment'}, {'measure': '2 Hour Glucose From Glucose Tolerance Test US Sample', 'timeFrame': 'between baseline and 3 months of study drug treatment', 'description': 'difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment'}], 'secondaryOutcomes': [{'measure': 'Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample', 'timeFrame': 'pre-treatment and 3 months of treatment', 'description': 'The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measure cognitive function in patients with schizophrenia. Range for list learning sub-score is 0 to 20 . Higher values indicate better performance. For change score (3 months -baseline) positive values indicate improved performance for this cognitive function and negative values indicate poorer performance on this cognitive function.'}, {'measure': 'Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample', 'timeFrame': 'pretreatment and during 3 months of drug treatment'}, {'measure': 'Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample', 'timeFrame': 'pretreatment and during 3 months of drug treatment'}, {'measure': '2 Hour Glucose From Glucose Tolerance Test China Sample', 'timeFrame': 'between baseline and 3 months of study drug treatment', 'description': 'difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment'}, {'measure': 'Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site', 'timeFrame': 'pretreatment and during 3 months of drug treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atypical antipsychotics', 'hyperglycemia', 'triglycerides', 'HDL', 'cholesterol', 'insulin resistance', 'schizophrenia', 'verbal memory'], 'conditions': ['Diabetes', 'Schizophrenia', 'Insulin Resistance', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Smith RC et al Pioglitazone as a treatment for glucose and lipid abnormalities in schizophrenic patents: A double-blind placebo controlled trial. NCDEU 51lst Annual Meeting Oral Presentation Abstract Book, 2011, p.13.'}, {'pmid': '23200554', 'type': 'RESULT', 'citation': 'Smith RC, Jin H, Li C, Bark N, Shekhar A, Dwivedi S, Mortiere C, Lohr J, Hu Q, Davis JM. Effects of pioglitazone on metabolic abnormalities, psychopathology, and cognitive function in schizophrenic patients treated with antipsychotic medication: a randomized double-blind study. Schizophr Res. 2013 Jan;143(1):18-24. doi: 10.1016/j.schres.2012.10.023. Epub 2012 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with first or second-generation antipsychotics, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline and during treatment with pioglitazone.', 'detailedDescription': 'The aim of this study is to investigate the effects of pioglitazone added to weight-lifestyle intervention vs. placebo plus lifestyle intervention on reversing or reducing impaired or abnormal triglycerides, HDL and glucose metabolism in schizophrenics treated with first or second-generation antipsychotics.. Another aim is to examine the effects of impaired glucose metabolism on verbal memory and other cognitive function in schizophrenic patients treated with these medications and the relationship to improvements in impaired glucose metabolism to impairments in cognitive function. Clozapine and olanzapine, and some other first or second-generation antipsychotics effective for treating schizophrenia and bipolar disorders, have been reported to be associated with increased incidence of diabetic type metabolic abnormalities, decreases in insulin sensitivity, and abnormal glucose tolerance tests. This can lead to the development of type 2 diabetes and also abnormal lipid metabolic levels which can lead to atherosclerotic changes and increased risk of cardiovascular disease and other diabetes related complications. Drug treatments which could reduce or correct these diabetic metabolic changes would permit many patients to continue to receive the benefits of these antipsychotic medications with reduced drug-induced comorbidity. Previous research using non-psychotic subjects has shown that diabetes and impaired glucose tolerance are associated with cognitive impairments, especially in verbal memory, and provides a rationale for testing whether corrections of impaired glucose metabolism are associated with cognitive improvements in schizophrenic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients will be males or females, 18-70 yrs of age, with a diagnosis of schizophrenia or schizoaffective disorder, and currently being treated with olanzapine or clozapine.\n2. Patients will have evidence of:\n\n 1. glucose levels indicating at least impaired fasting glucose: fasting glucose 100 mg/dL or 2 hr glucose tolerance test 140 mg/dL, or current treatment with oral antidiabetic drugs with history of hyperglycemia;\n 2. Triglyceride levels \\> 120 mg/dL and/or HDL levels \\< 40 mg/dL\n\nExclusion Criteria:\n\n1. Diabetes mellitus, type 1\n2. Recent diabetic ketoacidosis;\n3. Patients not currently treated with oral antidiabetic drugs but fasting is glucose 140 mg/dL \\[WHO criteria\\] on repeat testing in last three months, or random blood glucose \\>200 mg/dL plus 2 hr glucose on GTT \\>200 mg/dL; (these patients may need more immediate treatment with antidiabetic drugs and it is less certain if weight-lifestyle treatment would be effective in treating such high glucose levels);\n4. Patients with active liver disease with clinical abnormalities which need current treatment, or liver enzymes (Alt) 3 times upper limit for normal values in chart records in last year, or patients who are recorded as positive for hepatitis C;\n5. Congestive heart failure (Class III or IV cardiac status) or history of MI in medical record (because pioglitazone can increase blood volume slightly);\n6. Hematocrit greater than 10% below normal (hematocrit may be decreased 2 to 4% due to increased plasma volume);\n7. Female patients on current oral contraceptives (because pioglitazone may interfere with effects of some oral contraceptives);\n8. Patients taking ketoconazole,\n9. Patients who have started on atorvastatin or gemfibrozil in the past 2 months or have had a dose increase in atorvastatin in the last month (since these drugs can also lower triglycerides and raise HDL, recent start of therapy with these drugs could be a confound).\n10. Patients are not concomitantly treated with aripiprazole or ziprasidone.'}, 'identificationModule': {'nctId': 'NCT00231894', 'briefTitle': 'Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Nathan Kline Institute for Psychiatric Research'}, 'officialTitle': 'Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia Treated With Antipsychotic Medication And Potential Effects on Cognitive Function', 'orgStudyIdInfo': {'id': '04T-584 Stanley Foundation'}, 'secondaryIdInfos': [{'id': '04T-584', 'type': 'OTHER_GRANT', 'domain': 'Stanley Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone and life-style group', 'description': 'Pioglitazone (30-45 mg/daily) plus life-style diet group', 'interventionNames': ['Drug: Pioglitazone', 'Behavioral: Life style diet group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and life style group', 'description': 'Placebo capsules daily plus life-style diet group', 'interventionNames': ['Behavioral: Life style diet group', 'Other: Placebo']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'pioglitazone 30-45 mg/day', 'armGroupLabels': ['Pioglitazone and life-style group']}, {'name': 'Life style diet group', 'type': 'BEHAVIORAL', 'description': 'life style diet education group 1x/week', 'armGroupLabels': ['Pioglitazone and life-style group', 'Placebo and life style group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo comparator capsules', 'armGroupLabels': ['Placebo and life style group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10035', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Nathan Kline Institute for Psychiatric Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert C Smith, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine & Nathan Kline Institute for Psychiatric Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Psychiatrist', 'investigatorFullName': 'Robert C. Smith MD PhD', 'investigatorAffiliation': 'Nathan Kline Institute for Psychiatric Research'}}}}