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Trial Information
Generic NameRisperidoneProduct NameRISPERDAL CONSTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment559% Female49%% White80%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRISBIM3003Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)39.2
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
- 2024-0244 : Reevaluating Treatment Response Prediction in Mental Health: A Study on Generalizability
- 2022-5090 : Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS)
- 2022-5062 : Heterogeneous treatment effects estimation with multi-source data: evidence from bipolar disorder and schizophrenia trials
- 2022-4992 : Temporal trajectories of side-effects associated with antipsychotic treatment ? An individual participant data meta-analysis
- 2021-4575 : A NOVEL METHOD TO SUMMARIZE SAFETY IN CLINICAL TRIALS USING PHARMACOLOGICAL CLASS-RELATED RISKS IN FAERS
- 2020-4521 : Causally interpretable meta-analysis with missing data: Generalizing evidence from bipolar disorder and schizophrenia trials to a target population
- 2019-3978 : Safety of Risperidone and Paliperdone in schizophrenia and bipolar disorder diagnosed patients - a systematic review and meta-analysis
- 2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.
- 2019-3827 : Prediction of outcome and adverse events in antipsychotic treatment
- 2017-1846 : Discontinuation symptoms in antipsychotics: Individual patient level analyses of randomized controlled trials
- 2017-1521 : Predictors of Relapse following Maintenance Treatment of Antipsychotic Drug or Placebo in patients with SCZ, schizoaffective disorder and BPD
- 2016-1005 : Identification of multivariate, clinical patterns predicting treatment response to paliperidone in schizophrenia
- 2016-0880 : Incidence of death and other SAEs related to second generation antipsychotic or placebo treatment in RCTs - a systematic review and meta-analysis
- 2015-0649 : Population Representativeness of Clinical Trial Study Samples
- 2015-0644 : Generalizing treatment effects for bipolar disorder and schizophrenia to the US population: Generalizability of network meta-analysis
- 2015-0592 : Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques