NCT00266552 - The Safety And Efficacy Of Risperidone Versus Placebo In Conduct Disorder and Other Disruptive Behavior Disorders In Mild, Moderate And Borderline Mentally Retarded Children Aged 5 To 12 Years

CSR Summary
NCT00266552
Primary Citation
Data Specification Not Available

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL CONSTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment118% Female19%% White58%

Product ClassAtypical AntipsychoticsSponsor Protocol NumberCR006019 (RIS-USA-93)Data PartnerJohnson & JohnsonCondition StudiedAttention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Conduct DisorderMean/Median Age (Years)8

Supporting Documentation

Collected Datasets Available
Data Definition Specification Available
Protocol with Amendments Available
Statistical Analysis Plan Available
Clinical Study Report Available

Approved Data Requests Associated with this Trial

2022-4992 : Temporal trajectories of side-effects associated with antipsychotic treatment ? An individual participant data meta-analysis
2021-4754 : Harnessing clinical trial data to inform real-world clinical decision making in the treatment of schizophrenia
2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.
2017-1846 : Discontinuation symptoms in antipsychotics: Individual patient level analyses of randomized controlled trials
2016-0880 : Incidence of death and other SAEs related to second generation antipsychotic or placebo treatment in RCTs - a systematic review and meta-analysis
2015-0592 : Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques
2014-0317 : Risperidone for conduct problems: do improved indicators of emotional dysregulation mediate improved behavioral outcomes?

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Trial Information

Supporting Documentation

Approved Data Requests Associated with this Trial