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Trial Information
Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment111% Female32%% White53%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477-SCH-301Data PartnerJohnson & JohnsonCondition StudiedSchizophreniaMean/Median Age (Years)37.9
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
- 2024-0608 : Understanding treatment effects and symptom dynamics in schizophrenia using network analysis
- 2024-0280 : Individual-level and study-level predictors of placebo response and dropout in Schizophrenia Disorder clinical trials
- 2024-0008 : Sex differences in antipsychotic efficacy and side-effects in adults with acute exacerbations of schizophrenia: an individual-participant network meta-analysis
- 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
- 2021-4823 : Long term risk for relapse in patients suffering from schizophrenia randomized to oral placebo - A historical prospective study
- 2021-4754 : Harnessing clinical trial data to inform real-world clinical decision making in the treatment of schizophrenia
- 2021-4705 : Inflammation and the Metabolic Syndrome in Psychosis
- 2021-4667 : Estimation of Geographic and Demographic Variabilities Associated with Schizophrenia Age of Onset and Duration of Untreated Psychosis
- 2021-4620 : The effects of antipsychotic discontinuation and reinstatement
- 2020-4521 : Causally interpretable meta-analysis with missing data: Generalizing evidence from bipolar disorder and schizophrenia trials to a target population
- 2020-4517 : Metabolic side effects of antipsychotic drugs during medium- to long-term treatment in schizophrenia: Systematic review and network meta-analysis
- 2020-4454 : Inferential reproducibility of therapeutic research: a registered report for a cross-sectional study of RCTs available on major data-sharing platforms
- 2020-4175 : Placebo relapse after antipsychotic withdrawal: an individual participant meta-analysis
- 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
- 2019-3821 : Variability in antipsychotic response
- 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
- 2016-0766 : Gastrointestinal disease impact on antipsychotic induced weight gain and metabolic syndrome in schizophrenia: analysis of randomized controlled trials
- 2016-0725 : Investigation of Racial and Ethnic Differences in Cardiometabolic Health of Patients with Schizophrenia/Schizoaffective Disorder
- 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