Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-05 @ 3:36 AM
Study NCT ID:
NCT00288366
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2006-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'h-meltzer@northwestern.edu', 'phone': '1 312 503 0309', 'title': 'Herbert Y Meltzer', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole', 'description': 'aripiprazole (Abilify)\n\nziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 1, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ziprasidone', 'description': 'ziprasidone (Geodon)\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Worsening of psychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HDL Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'aripiprazole (Abilify)\n\nziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert'}, {'id': 'OG001', 'title': 'Ziprasidone', 'description': 'ziprasidone (Geodon)\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '43.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks from Baseline', 'description': 'change in HDL ratio after medication switch', 'unitOfMeasure': "unit of Measure ''g/dL''", 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole', 'description': 'aripiprazole (Abilify)\n\nziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert'}, {'id': 'FG001', 'title': 'Ziprasidone', 'description': 'ziprasidone (Geodon)\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole', 'description': 'aripiprazole (Abilify)\n\nziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert'}, {'id': 'BG001', 'title': 'Ziprasidone', 'description': 'ziprasidone (Geodon)\n\naripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '44.9', 'spread': '8.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2006-02-06', 'resultsFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-16', 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL Ratio', 'timeFrame': '24 weeks from Baseline', 'description': 'change in HDL ratio after medication switch'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizoaffective disorder', 'bipolar disorder', 'metabolic syndrome'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.\n\nThe metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nTo be eligible, patients must :\n\n* Be male or female, age 18-65\n* Be diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria\n* Be currently receiving antipsychotic drugs (clozapine, haloperidol, olanzapine, quetiapine, or risperidone) (APDs) alone, mood stabilizer(s) (MS) alone, or a combination of the two\n* Have a history of compliance with the above medication\n* Have presumptive IRS as indicated by a TG/HDL ratio \\> 3.5 on current antipsychotic medication\n* Be Medicaid eligible or maintain insurance covering requested lab procedures\n* Be able to provide written informed consent Exclusion criteria\n\nA patient will be considered ineligible if he/she:\n\n* Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.\n* Has a history of noncompliance with prescribed psychiatric medications\n* Has a TG/HDL ratio \\< 3.5 on current medication\n* Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.\n* Is unable to provide written informed consent.\n* (Females only) Is pregnant, lactating or plans to become pregnant during study participation\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00288366', 'briefTitle': 'Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome', 'orgStudyIdInfo': {'id': '050942'}, 'secondaryIdInfos': [{'id': 'NARSAD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'aripiprazole (Abilify)', 'interventionNames': ['Drug: ziprasidone vs. aripiprazole', 'Drug: aripiprazole vs. ziprasidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'ziprasidone (Geodon)', 'interventionNames': ['Drug: aripiprazole vs. ziprasidone']}], 'interventions': [{'name': 'ziprasidone vs. aripiprazole', 'type': 'DRUG', 'description': 'ziprasidone vs. aripiprazole dosed according to package insert', 'armGroupLabels': ['1']}, {'name': 'aripiprazole vs. ziprasidone', 'type': 'DRUG', 'description': 'aripiprazole vs. ziprasidone dosed according to package insert', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Psychiatric Hospital at Vanderbilt', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Yuejin Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Alliance for Research on Schizophrenia and Depression', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Herbert Meltzer', 'investigatorAffiliation': 'Vanderbilt University'}}}}