NCT00309686 - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder

CSR Summary
NCT00309686
Primary Citation
Data Specification

Trial Information

Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment300% Female46%% White77%

Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477-BIM-3003Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)40

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
2020-4521 : Causally interpretable meta-analysis with missing data: Generalizing evidence from bipolar disorder and schizophrenia trials to a target population
2019-4080 : Explainable Artificial Intelligence Models for Personalized Prediction of Treatment Response in Neurobehavioral Disorders
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
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
2015-0644 : 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