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Trial Information
Generic NameRisperidoneProduct NameRISPERDAL CONSTA®Therapeutic AreaNervous SystemProduct ClassPsycholepticsPharmacological SubgroupAntipsychoticsChemical SubgroupOther AntipsychoticsCondition StudiedAttention Deficit and Disruptive Behavior Disorders
Sponsor Protocol NumberCR002020 (RIS-INT-79)Enrollment375Data PartnerJohnson & Johnson% Female13%Mean/Median Age (Years)11.1% White87%
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