Trial Information
Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaBehaviors and Mental DisordersEnrollment101% FemaleN/A% WhiteN/A
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-USA-150Data PartnerJohnson & JohnsonCondition StudiedAutistic DisorderMean/Median Age (Years)N/A
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
- 2021-4766 : Early Prediction of Treatment Response to Antipsychotics for Irritability and Aggression in Autism Spectrum Disorder
- 2021-4575 : A NOVEL METHOD TO SUMMARIZE SAFETY IN CLINICAL TRIALS USING PHARMACOLOGICAL CLASS-RELATED RISKS IN FAERS
- 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