Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Nctid: NCT00001656

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Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.19", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisGroupDescription"=>"Analysis of covariance with baseline score as covariate", "OutcomeAnalysisStatisticalMethod"=>"ANCOVA", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Covariate is baseline score", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in the Scale for the Assessment of Positive Symptoms", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.", "OutcomeMeasureUnitOfMeasure"=>"Scores on a scale", "OutcomeMeasureDispersionType"=>"95% Confidence Interval", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"-3.1", "OutcomeMeasurementGroupId"=>"OG000", "OutcomeMeasurementLowerLimit"=>"-5.0", "OutcomeMeasurementUpperLimit"=>"-1.2"}, {"OutcomeMeasurementValue"=>"-4", "OutcomeMeasurementGroupId"=>"OG001", "OutcomeMeasurementLowerLimit"=>"-5.3", "OutcomeMeasurementUpperLimit"=>"-2.7"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.59", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisGroupDescription"=>"Analysis of covariance with baseline score as covariate", "OutcomeAnalysisStatisticalMethod"=>"ANCOVA", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Covariate is baseline score", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in the Bunney-Hamburg Rating Scale for Psychosis", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.", "OutcomeMeasureUnitOfMeasure"=>"Scores on a scale", "OutcomeMeasureDispersionType"=>"95% Confidence Interval", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"0.4", "OutcomeMeasurementGroupId"=>"OG000", "OutcomeMeasurementLowerLimit"=>"-0.6", "OutcomeMeasurementUpperLimit"=>"1.4"}, {"OutcomeMeasurementValue"=>"0.2", "OutcomeMeasurementGroupId"=>"OG001", "OutcomeMeasurementLowerLimit"=>"-0.5", "OutcomeMeasurementUpperLimit"=>"0.8"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.72", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisGroupDescription"=>"Analysis of covariance with baseline score as covariate", "OutcomeAnalysisStatisticalMethod"=>"ANCOVA", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in Bunney-Hamburg Rating Scale for Depression", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.", "OutcomeMeasureUnitOfMeasure"=>"Scores on a scale", "OutcomeMeasureDispersionType"=>"95% Confidence Interval", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"-0.4", "OutcomeMeasurementGroupId"=>"OG000", "OutcomeMeasurementLowerLimit"=>"-2.3", "OutcomeMeasurementUpperLimit"=>"1.5"}, {"OutcomeMeasurementValue"=>"-0.8", "OutcomeMeasurementGroupId"=>"OG001", "OutcomeMeasurementLowerLimit"=>"-1.7", "OutcomeMeasurementUpperLimit"=>"0.1"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.27", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisGroupDescription"=>"Analysis of covariance with baseline score as covariate", "OutcomeAnalysisStatisticalMethod"=>"ANCOVA", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Covariate is baseline score", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in Bunney-Hamburg Rating Scale for Mania", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.", "OutcomeMeasureUnitOfMeasure"=>"Scores on a scale", "OutcomeMeasureDispersionType"=>"95% Confidence Interval", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"-0.5", "OutcomeMeasurementGroupId"=>"OG000", "OutcomeMeasurementLowerLimit"=>"-1.6", "OutcomeMeasurementUpperLimit"=>"0.5"}, {"OutcomeMeasurementValue"=>"0.6", "OutcomeMeasurementGroupId"=>"OG001", "OutcomeMeasurementLowerLimit"=>"-2.3", "OutcomeMeasurementUpperLimit"=>"1.1"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.11", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisStatisticalMethod"=>"ANCOVA", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Covariate is baseline score", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in the Bunney-Hamburg Rating Scale for Anxiety", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.", "OutcomeMeasureUnitOfMeasure"=>"Scores on a scale", "OutcomeMeasureDispersionType"=>"95% Confidence Interval", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"3.6", "OutcomeMeasurementSpread"=>"4.0", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"3.8", "OutcomeMeasurementSpread"=>"6.0", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Other Pre-specified", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.96", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisStatisticalMethod"=>"t-test, 2 sided", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in Weight", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureUnitOfMeasure"=>"kilograms", "OutcomeMeasureDispersionType"=>"Standard Deviation", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"1.4", "OutcomeMeasurementSpread"=>"1.6", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"1.6", "OutcomeMeasurementSpread"=>"2.5", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Other Pre-specified", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.76", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisStatisticalMethod"=>"t-test, 2 sided", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in Body Mass Index (BMI)", "OutcomeMeasureParamType"=>"Mean", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)", "OutcomeMeasureUnitOfMeasure"=>"kg/m²", "OutcomeMeasureDispersionType"=>"Standard Deviation", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"0", "OutcomeMeasurementGroupId"=>"OG000", "OutcomeMeasurementLowerLimit"=>"-9", "OutcomeMeasurementUpperLimit"=>"4"}, {"OutcomeMeasurementValue"=>"0", "OutcomeMeasurementGroupId"=>"OG001", "OutcomeMeasurementLowerLimit"=>"-4", "OutcomeMeasurementUpperLimit"=>"8"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Other Pre-specified", "OutcomeMeasureTitle"=>"Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)", "OutcomeMeasureParamType"=>"Median", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"minimum score = 10; maximum score = 50; lower score is considered a more favorable outcome", "OutcomeMeasureUnitOfMeasure"=>"scores on a scale", "OutcomeMeasureDispersionType"=>"Full Range", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"0", "OutcomeMeasurementGroupId"=>"OG000", "OutcomeMeasurementLowerLimit"=>"-2", "OutcomeMeasurementUpperLimit"=>"1"}, {"OutcomeMeasurementValue"=>"0", "OutcomeMeasurementGroupId"=>"OG001", "OutcomeMeasurementLowerLimit"=>"-3", "OutcomeMeasurementUpperLimit"=>"1"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"13", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Olanzapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Clozapine Group", "OutcomeGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "OutcomeMeasureType"=>"Other Pre-specified", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.73", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisStatisticalMethod"=>"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score", "OutcomeMeasureParamType"=>"Median", "OutcomeMeasureTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OutcomeMeasureDescription"=>"minimum score = 10; maximum score = 90; lower score considered a more favorable outcome", "OutcomeMeasureUnitOfMeasure"=>"scores on a scale", "OutcomeMeasureDispersionType"=>"95% Confidence Interval", "OutcomeMeasureReportingStatus"=>"Posted"}]}}, "ParticipantFlowModule"=>{"FlowGroupList"=>{"FlowGroup"=>[{"FlowGroupId"=>"FG000", "FlowGroupTitle"=>"Olanzapine Group", "FlowGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"FlowGroupId"=>"FG001", "FlowGroupTitle"=>"Clozapine Group", "FlowGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}]}, "FlowPeriodList"=>{"FlowPeriod"=>[{"FlowPeriodTitle"=>"Overall Study", "FlowMilestoneList"=>{"FlowMilestone"=>[{"FlowMilestoneType"=>"STARTED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"13"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"12"}]}}, {"FlowMilestoneType"=>"COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"12"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"12"}]}}, {"FlowMilestoneType"=>"NOT COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"1"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"0"}]}}]}}]}}, "BaselineCharacteristicsModule"=>{"BaselineDenomList"=>{"BaselineDenom"=>[{"BaselineDenomUnits"=>"Participants", "BaselineDenomCountList"=>{"BaselineDenomCount"=>[{"BaselineDenomCountValue"=>"13", "BaselineDenomCountGroupId"=>"BG000"}, {"BaselineDenomCountValue"=>"12", "BaselineDenomCountGroupId"=>"BG001"}, {"BaselineDenomCountValue"=>"25", "BaselineDenomCountGroupId"=>"BG002"}]}}]}, "BaselineGroupList"=>{"BaselineGroup"=>[{"BaselineGroupId"=>"BG000", "BaselineGroupTitle"=>"Olanzapine Group", "BaselineGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"BaselineGroupId"=>"BG001", "BaselineGroupTitle"=>"Clozapine Group", "BaselineGroupDescription"=>"All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine."}, {"BaselineGroupId"=>"BG002", "BaselineGroupTitle"=>"Total", "BaselineGroupDescription"=>"Total of all reporting groups"}]}, "BaselineMeasureList"=>{"BaselineMeasure"=>[{"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"<=18 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"13", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"12", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"25", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Between 18 and 65 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>">=65 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Age, Categorical", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"12.8", "BaselineMeasurementSpread"=>"2.4", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"11.7", "BaselineMeasurementSpread"=>"2.3", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"12.2", "BaselineMeasurementSpread"=>"2.1", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Age Continuous", "BaselineMeasureParamType"=>"Mean", "BaselineMeasureUnitOfMeasure"=>"years", "BaselineMeasureDispersionType"=>"Standard Deviation"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Female", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"6", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"4", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"10", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Male", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"7", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"8", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"15", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Sex: Female, Male", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"American Indian or Alaska Native", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Asian", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Black or African American", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"4", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"3", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"7", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"White", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"7", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"8", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"15", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"More than one race", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Unknown or Not Reported", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Race (NIH/OMB)", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"United States", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"13", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"12", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"25", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Region of Enrollment", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Triple", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Care Provider", "Investigator"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"25"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"June 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2011", "CompletionDateStruct"=>{"CompletionDate"=>"June 2008", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"March 11, 2011", "StudyFirstSubmitDate"=>"November 3, 1999", "ResultsFirstSubmitDate"=>"March 2, 2011", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 12, 2011", "LastUpdatePostDateType"=>"Estimate"}, "ResultsFirstSubmitQCDate"=>"March 11, 2011", "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "ResultsFirstPostDateStruct"=>{"ResultsFirstPostDate"=>"April 12, 2011", "ResultsFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2008", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"OtherOutcomeList"=>{"OtherOutcome"=>[{"OtherOutcomeMeasure"=>"Change in Weight", "OtherOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks"}, {"OtherOutcomeMeasure"=>"Change in Body Mass Index (BMI)", "OtherOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OtherOutcomeDescription"=>"BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)"}, {"OtherOutcomeMeasure"=>"Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)", "OtherOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OtherOutcomeDescription"=>"minimum score = 10; maximum score = 50; lower score is considered a more favorable outcome"}, {"OtherOutcomeMeasure"=>"Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score", "OtherOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "OtherOutcomeDescription"=>"minimum score = 10; maximum score = 90; lower score considered a more favorable outcome"}]}, "PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Change in the Scale for the Assessment of Negative Symptoms", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome"}, {"PrimaryOutcomeMeasure"=>"Change in the Clinical Global Impression Severity of Symptoms Scale", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome."}, {"PrimaryOutcomeMeasure"=>"Change in the Brief Psychiatric Rating Scale-24", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome."}, {"PrimaryOutcomeMeasure"=>"Change in the Scale for the Assessment of Positive Symptoms", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome."}, {"PrimaryOutcomeMeasure"=>"Change in the Bunney-Hamburg Rating Scale for Psychosis", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome."}, {"PrimaryOutcomeMeasure"=>"Change in Bunney-Hamburg Rating Scale for Depression", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome."}, {"PrimaryOutcomeMeasure"=>"Change in Bunney-Hamburg Rating Scale for Mania", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome."}, {"PrimaryOutcomeMeasure"=>"Change in the Bunney-Hamburg Rating Scale for Anxiety", "PrimaryOutcomeTimeFrame"=>"8 week double-blind study period; baseline and 8 weeks", "PrimaryOutcomeDescription"=>"Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome."}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Clozapine", "Olanzapine", "Drug Response", "Safety", "Childhood Onset Schizophrenia", "Schizoaffective Disorder", "Multidimensionally Impaired Syndrome", "Phenomenology", "Biochemical Correlates", "Brain Imaging", "Schizophrenia", "Childhood Schizophrenia", "Psychosis"]}, "ConditionList"=>{"Condition"=>["Childhood Schizophrenia", "Psychotic Disorder", "Schizophrenia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7701277", "ReferenceType"=>"background", "ReferenceCitation"=>"Gordon CT, Frazier JA, McKenna K, Giedd J, Zametkin A, Zahn T, Hommer D, Hong W, Kaysen D, Albus KE, et al. Childhood-onset schizophrenia: an NIMH study in progress. Schizophr Bull. 1994;20(4):697-712. doi: 10.1093/schbul/20.4.697."}, {"ReferencePMID"=>"10578456", "ReferenceType"=>"background", "ReferenceCitation"=>"Nicolson R, Rapoport JL. Childhood-onset schizophrenia: rare but worth studying. Biol Psychiatry. 1999 Nov 15;46(10):1418-28. doi: 10.1016/s0006-3223(99)00231-0."}, {"ReferencePMID"=>"16818861", "ReferenceType"=>"result", "ReferenceCitation"=>"Shaw P, Sporn A, Gogtay N, Overman GP, Greenstein D, Gochman P, Tossell JW, Lenane M, Rapoport JL. Childhood-onset schizophrenia: A double-blind, randomized clozapine-olanzapine comparison. Arch Gen Psychiatry. 2006 Jul;63(7):721-30. doi: 10.1001/archpsyc.63.7.721."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"http://clinicalstudies.info.nih.gov/detail/B_1997-M-0126.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to compare the effectiveness and side effects of the drugs clozapine and olanzapine in children and adolescents with schizophrenia and psychoses.\n\nChildhood psychosis is a serious disorder that may have devastating consequences. Effective treatments for the condition are under continual investigation. This study will examine the causes of and offer treatment for childhood psychosis.\n\nParticipants in this study will undergo psychological tests, blood and urine tests, electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI) scans of the brain for the first 1 to 2 weeks of the study while taking their regular medications. Participants will then be tapered off their medications over 1 to 3 weeks and will continue to stay off medications for an additional 2 days to 3 weeks. During this time, participants will undergo psychiatric, neurological, and cardiac examinations as well as blood tests. After this period without medications, participants will be randomly assigned to receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to treatment and after 6 weeks of study medication. Participants who respond well to the study drugs may continue to receive them through their own physician. Participants who do not respond to either clozapine or olanzapine or cannot tolerate their side effects will be treated individually with other drugs until optimum treatment is identified. Regular telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.", "DetailedDescription"=>"The purpose of this protocol is to compare efficacy of clozapine and olanzapine in children and adolescents with schizophrenia and psychoses, as well as to learn about side effects of these medication in pediatric population. The underlying hypothesis is that clozapine has superior efficacy over olanzapine.\n\nChildren and adolescents, ages 7 to 18 years, meeting DSM-IV criteria for schizophrenia, schizoaffective disorder and psychotic disorder not otherwise specified, with onset of psychosis before their 13th birthday, who have not responded to at least two prior trials with typical or a typical neuroleptics, will be eligible to participate in a double-blind, parallel group, trial of olanzapine-clozapine.\n\nThis study will be done in conjunction with the Screening protocol, which will include characterization by clinical phenomenology, eye tracking, MRI brain imaging, plasma biochemistry, and chromosomal analysis.\n\nThis study will consist of the following phases 1) Tapering of psychotropic medications (1-4 weeks, depending upon type and dosage). 2) Observation for up to 2 weeks drug free, in order to establish a baseline prior to starting medication trial. 3) An 8 week double-blind trial of either clozapine or olanzapine. Efficacy and tolerability of clozapine and olanzapine will be compared using specified criteria. 4) If desired improvement not achieved or trial is interrupted, an 8 week open trial of the second medication and 5) Discharge following medication optimization for up to 4 weeks, or as clinically appropriate. This protocol also includes a follow-up every 2 to 3 years for a period of 10 years."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"18 years", "MinimumAge"=>"7 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nMales and females, age 7 to 18 years\n\nOnset of psychotic symptoms before 13th birthday and a DSM-IV diagnosis of either schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS (not otherwise specified).\n\nCurrent significant impairment due to the illness (current psychotic symptoms, decline of functioning academically and socially, significant discomfort due to psychotic symptoms).\n\nFailure of two prior trials with antipsychotic medications (either typical or atypical) used at adequate doses (greater than or equal to 100 mg/day in chlorpromazine equivalents) and for adequate duration (at least 4 weeks, unless terminated due to intolerable side effects). Failure is defined as either insufficient response with persistence of symptoms significantly impairing child's functioning, according to child's and parental reports and medical and school records, or intolerable side effects to drugs other than clozapine and olanzapine.\n\nSubjects may be included if their previous trial(s) of olanzapine failed to reach the dose of 20. mg/day or a duration of fewer than four weeks.\n\nSubjects may be included if their previous trial(s) of clozapine failed to reach the dose of 200. mg/day or a duration of fewer than six weeks.\n\nComorbid psychiatric disorders in the past 12 months are permitted as long as not clinically significant.\n\nEXCLUSION CRITERIA:\n\nPrepsychotic full-scale IQ less than 70.\n\nUnstable major neurological or medical conditions.\n\nCurrent pregnancy or plan to become pregnant during the first three months (the duration of the study) in woman of childbearing age; breast-feeding in woman with infants.\n\nDSM-IV substance abuse or dependence in the past 6 months.\n\nTrue non-responders to either olanzapine or clozapine. True non-response is defined as: a) intolerance to either of the medications preventing an adequate trial, or b) only minimal (less than 20%) benefit with the adequate trial of either of the medications. Adequate trial constitutes at least 8 weeks of the medication with the dose of 20 mg on olanzapine or 200 mg of clozapine."}, "IdentificationModule"=>{"NCTId"=>"NCT00001656", "BriefTitle"=>"Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Childhood Onset Psychotic Disorders: Characterization and Treatment With Atypical Neuroleptics", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970126"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-M-0126"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Olanzapine", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Olanzapine"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Clozapine", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Clozapine"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Olanzapine", "InterventionType"=>"Drug", "InterventionDescription"=>"tablet; 5-20mg/day; 8 weeks", "InterventionOtherNameList"=>{"InterventionOtherName"=>["\"Zyprexa\""]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Olanzapine"]}}, {"InterventionName"=>"Clozapine", "InterventionType"=>"Drug", "InterventionDescription"=>"tablet; 12.5-900mg/day; 8 weeks", "InterventionOtherNameList"=>{"InterventionOtherName"=>["\"Clozaril\""]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Clozapine"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Judith L Rapoport, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Child Psychiatry Branch, NIMH, NIH"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Mental Health (NIMH)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyOldNameTitle"=>"Judith L. Rapoport, M.D./National Institute of Mental Health", "ResponsiblePartyOldOrganization"=>"National Institutes of Health"}}}}}}