Trial Information
Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment201% Female41%% White68%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477PSZ3001Data PartnerJohnson & JohnsonCondition StudiedSchizophreniaMean/Median Age (Years)15
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
- 2024-0364 : Robust hyperparameter selection needed to build generalizable clinical prediction models
- 2024-0280 : Individual-level and study-level predictors of placebo response and dropout in Schizophrenia Disorder clinical trials
- 2024-0272 : An evaluation of lack of early improvement and later non-response in early-onset schizophrenia: a systematic review and diagnostic test accuracy meta-analysis of data from randomized controlled trials.
- 2024-0268 : Use of machine learning for discerning prognostic and predictive features in schizophrenia disease and evaluating their generalizability
- 2024-0244 : Reevaluating Treatment Response Prediction in Mental Health: A Study on Generalizability
- 2024-0056 : Multi-study causal inference for robust clinical outcome predictions
- 2024-0052 : Generalizability of clinical prediction models using synthetic data generated through random sampling
- 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.
- 2020-4454 : Inferential reproducibility of therapeutic research: a registered report for a cross-sectional study of RCTs available on major data-sharing platforms
- 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.
- 2019-3941 : 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
- 2017-1676 : Placebo Effects in Schizophrenia
- 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
- 2015-0592 : Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques
- 2014-0364 : Initial severity and efficacy of antipsychotics for schizophrenia and bipolar mania: Individual patient level analyses of placebo-controlled trials