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Trial Information
Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment228% Female34%% White76%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477PSZ3003Data PartnerJohnson & JohnsonCondition StudiedSchizophreniaMean/Median Age (Years)15.3
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
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- 2024-0268 : Use of machine learning for discerning prognostic and predictive features in schizophrenia disease and evaluating their generalizability
- 2024-0008 : Sex differences in antipsychotic efficacy and side-effects in adults with acute exacerbations of schizophrenia: an individual-participant network meta-analysis
- 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
- 2020-4528 : Validation of a shortened PANSS for use in clinical trials of adolescent schizophrenia.
- 2020-4517 : Metabolic side effects of antipsychotic drugs during medium- to long-term treatment in schizophrenia: Systematic review and network meta-analysis
- 2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.
- 2019-3941 : Factors moderating estimates of antipsychotic efficacy in schizophrenia
- 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
- 2016-1005 : Identification of multivariate, clinical patterns predicting treatment response to paliperidone in schizophrenia
- 2016-0766 : Gastrointestinal disease impact on antipsychotic induced weight gain and metabolic syndrome in schizophrenia: analysis of randomized controlled trials
- 2015-0592 : Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques