Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-02 @ 11:11 PM
Study NCT ID:
NCT00205660
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yinglinm@wustl.edu', 'phone': '5735791412', 'title': 'Michael Yingling', 'organization': 'Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the entire course of the 12-week study.', 'eventGroups': [{'id': 'EG000', 'title': 'Stay', 'description': 'Includes subjects who stayed on their current antipsychotic throughout the study', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Switch', 'description': 'Includes subjects who switched to aripiprazole', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 17, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hunger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness/Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Body Fat (kg).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stayers', 'description': 'The subjects in this arm stayed on their current antipsychotic following entry into the study.'}, {'id': 'OG001', 'title': 'Switchers', 'description': 'The subjects in this arm switched to aripiprazole from their current antipsychotic following entry into the study.'}, {'id': 'OG002', 'title': 'Total', 'description': 'This arm consists of pooled treatment groups (i.e., those who stayed on their current antipsychotic and those who switched to aripiprazole).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '-1.27', 'spread': '2.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance in this planned primary test was p\\<0.05.', 'groupDescription': 'A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.', 'unitOfMeasure': 'change in kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was "per protocol" and included subjects that completed both a baseline and endpoint assessment, which in this case, was a DEXA scan.'}, {'type': 'PRIMARY', 'title': 'Change in Whole Body Sensitivity (mg/kg/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stayers', 'description': 'The subjects in this arm stayed on their current antipsychotic following entry into the study.'}, {'id': 'OG001', 'title': 'Switchers', 'description': 'The subjects in this arm switched to aripiprazole from their current antipsychotic following entry into the study.'}, {'id': 'OG002', 'title': 'Total', 'description': 'This arm consists of pooled treatment groups (i.e., those who stayed on their current antipsychotic and those who switched to aripiprazole).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '0.70', 'spread': '2.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance in this planned primary test was p\\<0.05.', 'groupDescription': 'A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'This study hypothesized that switching to aripiprazole treatment will be associated with statistically significant improvements in whole body sensitivity (mg/kg/min) in comparison to chronic pretreatment with olanzapine.', 'unitOfMeasure': 'change in mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was "per protocol" and included subjects that completed both a baseline and endpoint assessment, which in this case, was a hyperinsulinemic euglycemic clamp.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stayers', 'description': 'Participants in this arm were randomized to stay on their current antipsychotic.'}, {'id': 'FG001', 'title': 'Switchers', 'description': 'Participants in this arm were randomized to switch to aripiprazole from their current antipsychotic.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from wide range of sites in the St. Louis community. Some advertising with flyers was used however the majority of the recruitment was done using community outreach, doctor-to-doctor or self-referrals, and referrals from board and care and community support programs. All recruitment materials were approved by the IRB.', 'preAssignmentDetails': 'Participants were enrolled in the study once they signed consent. After enrollment, participants were brought in for a screening visit consisting of a diagnostic interview, screening labs, a review of records and a discussion with their primary psychiatrist. If the patient met all inclusion criteria after screening, study visits were scheduled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stay', 'description': 'Subjects in this group stayed on their current antipsychotic.'}, {'id': 'BG001', 'title': 'Switch', 'description': 'Subjects in this group switched to aripiprazole from their current antipsychotic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.5', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Non-White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '18.7', 'groupId': 'BG000'}, {'value': '91.4', 'spread': '20.1', 'groupId': 'BG001'}, {'value': '92.0', 'spread': '19.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per squared meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101.8', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '103.7', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '103.2', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant was missing a waist measurement.'}, {'title': 'DEXA Total Fat', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant was missing a DEXA.'}, {'title': 'Whole Body Sensitivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-20', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Body Fat (kg).', 'timeFrame': '12 Weeks', 'description': 'This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.'}, {'measure': 'Change in Whole Body Sensitivity (mg/kg/Min)', 'timeFrame': '12 Weeks', 'description': 'This study hypothesized that switching to aripiprazole treatment will be associated with statistically significant improvements in whole body sensitivity (mg/kg/min) in comparison to chronic pretreatment with olanzapine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Obesity', 'Hyperglycemia', 'Dyslipidemia', 'Type 2 Diabetes Mellitus'], 'conditions': ['Schizophrenia', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '11806485', 'type': 'BACKGROUND', 'citation': 'Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1.'}]}, 'descriptionModule': {'briefSummary': 'This proposal aims to use well-validated methodologies such as dual energy x-ray absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine, risperidone or ziprasidone.\n\nWe hypothesize that switching to aripiprazole treatment will induce improvements in total body adiposity, inflammation (e.g., high sensitivity C-reactive protein \\[hsCRP\\]), glucose metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and quetiapine.', 'detailedDescription': 'Schizophrenia is associated with increased rates of obesity, hyperglycemia, dyslipidemia and type 2 diabetes mellitus (T2DM), causing increased morbidity and mortality due to acute (e.g., diabetic ketoacidosis) and long-term (e.g., vascular disease) complications.1-5As a result, cardiovascular (CV) mortality remains one of the leading causes of excess mortality in patients with psychotic disorders.6,7 T2DM is characterized by disturbances in insulin secretion and insulin action at skeletal muscle (i.e., decreased glucose disposal), liver (i.e., increased glucose production) and adipose tissue (i.e., increased lipolysis), leading to disturbances in glucose and lipid metabolism. The metabolic syndrome of insulin resistance, hyperinsulinemia, dyslipidemia and abdominal adiposity usually includes a procoagulant state and endothelial dysfunction, and is strongly associated with increased CV morbidity and mortality.\n\nHyperglycemia was first noted in patients with schizophrenia prior to the introduction of antipsychotic medications, but glucoregulatory defects, dyslipidemia and increased adiposity are all additionally associated with both older and newer antipsychotic treatments.1 In most patients, these metabolic derangements are primarily related to increases in adiposity, although treatment effects independent of adiposity may also play a role in up to 25% of cases of new onset T2DM during antipsychotic treatment.8,9 Increased adiposity, especially visceral abdominal adiposity, is associated with insulin resistance, elevated plasma lipids, and increases in inflammatory markers. All of these conditions contribute to elevated mortality and all can be directly measured in patients treated with different medications.\n\nDirect measures of adiposity, insulin action and secretion, plasma lipid levels and inflammation are available and have been well validated as predictors of CV disease and T2DM complications. Unfortunately, to date, studies using large population-based samples of patients taking antipsychotic medications have only used insensitive measures, like random glucose, or surrogate measures such as prescription of an oral hypoglycemic agent, to estimate the prevalence of T2DM during antipsychotic treatment. No data are available concerning insulin sensitivity and secretion, plasma lipids or inflammatory markers from large population-based samples of individuals treated with antipsychotic medications. Reviewed below, limited data are available from smaller analytic studies using sensitive measures. Despite convergent evidence for the contribution of adiposity to the metabolic derangements associated with antipsychotic treatment, investigators have only begun to use direct measures of adiposity to characterize the weight gain associated with antipsychotic treatment.\n\nThis proposal aims to use well-validated methodologies such as dual energy x-ray absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine, risperidone or ziprasidone.\n\nWe hypothesize that switching to aripiprazole treatment will induce improvements in total body adiposity, inflammation (e.g., high sensitivity C-reactive protein \\[hsCRP\\]), glucose metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and quetiapine.\n\nAim 1: To characterize the glucoregulatory effects of 12 weeks of aripiprazole treatment.\n\nThis study hypothesizes that switching to aripiprazole treatment will be associated with statistically significant improvements in glucose metabolism (e.g., insulin sensitivity) in comparison to chronic pretreatment with olanzapine. Given the planned sample size and study duration, we hypothesize that aripiprazole treatment will be associated with numerical, but not statistically significant, improvements in comparison to pretreatment with risperidone or quetiapine. We hypothesize that aripiprazole treatment will be associated with no significant change in comparison to pretreatment with ziprasidone. These hypotheses will be evaluated by measuring insulin sensitivity and other indices via fsOGTTs and hyperinsulinemic euglycemic clamps.\n\nAim 2: To evaluate medication-related measures of abdominal fat, total body fat and total fat-free mass.\n\nThis study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine. We hypothesize that aripiprazole treatment will be associated with numerical, but not statistically significant, reductions in comparison to pretreatment with risperidone or quetiapine. We hypothesize that aripiprazole treatment will be associated with no change in comparison to pretreatment with ziprasidone. These hypotheses will be evaluated by measuring body composition using dual energy x-ray absorptiometry (DEXA) and anthropomorphic measurements to provide estimates of total body fat, abdominal fat and fat-free mass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets DSM-IV criteria for Schizophrenia\n* 18-60 years of age or older\n* Able to give informed consent\n* Treated with olanzapine, quetiapine, risperidone or ziprasidone for greater than or equal to 3 months prior to enrollment\n\nExclusion Criteria:\n\n* pregnant or breastfeeding women will be excluded\n* Meets DSM-IV criteria for substance abuse or dependence within past 6 months\n* involuntary legal status (as per Missouri law)\n* any serious medical disorder that may confound assessment of symptoms\n* subjects taking prescription medications except psychotropic meds\n* meets DSM-IV criteria for Mental Retardation (mild or worse)\n* Subjects taking tricyclic antidepressants or mood stabilizers'}, 'identificationModule': {'nctId': 'NCT00205660', 'acronym': 'BMS', 'briefTitle': 'Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Changes in Adiposity and Metabolic Measures During Medication Switches to Aripiprazole From Other Atypical Antipsychotics', 'orgStudyIdInfo': {'id': 'BMS #942370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stayers', 'description': 'Subjects are randomized to stay on their current antipsychotic.', 'interventionNames': ['Other: Stayers']}, {'type': 'OTHER', 'label': 'Switchers', 'description': 'Subjects are randomized to switch to aripiprazole from their current antipsychotic.', 'interventionNames': ['Other: Switchers']}], 'interventions': [{'name': 'Stayers', 'type': 'OTHER', 'description': 'Participants remain on their current antipsychotic.', 'armGroupLabels': ['Stayers']}, {'name': 'Switchers', 'type': 'OTHER', 'description': 'Subjects are randomized to switch to aripiprazole from their current antipsychotic.', 'armGroupLabels': ['Switchers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'John W. Newcomer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine and Florida Atlantic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}