NCT00752427 - 24 week extension of NCT00085748: A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Paliperidone Extended Release in the Treatment of Geriatric Patients With Schizophrenia

CSR Summary
NCT00752427
Primary Citation
Data Specification

Trial Information

Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment88% Female73%% WhiteN/A

Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477-SCH-702Data PartnerJohnson & JohnsonCondition StudiedSchizophreniaMean/Median Age (Years)69.4

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

2024-0268 : Use of machine learning for discerning prognostic and predictive features in schizophrenia disease and evaluating their generalizability
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
2021-4754 : Harnessing clinical trial data to inform real-world clinical decision making in the treatment of schizophrenia
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
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
2016-1005 : Identification of multivariate, clinical patterns predicting treatment response to paliperidone in schizophrenia
2015-0644 : Generalizing treatment effects for bipolar disorder and schizophrenia to the US population: Generalizability of network meta-analysis

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Trial Information

Supporting Documentation

Approved Data Requests Associated with this Trial