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Trial Information
Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment307% Female44.1%% White51.3%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477SCA3002Data PartnerJohnson & JohnsonCondition StudiedSchizoaffective Disorder, SchizophreniaMean/Median Age (Years)37.6
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
- 2022-4992 : 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
- 2021-4568 : Motor side effects and antipsychotic efficacy of antipsychotic drugs: An individual participant meta-analysis
- 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.
- 2019-3941 : Factors moderating estimates of antipsychotic efficacy in schizophrenia
- 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
- 2016-0880 : Incidence of death and other SAEs related to second generation antipsychotic or placebo treatment in RCTs - a systematic review and meta-analysis
- 2016-0725 : Investigation of Racial and Ethnic Differences in Cardiometabolic Health of Patients with Schizophrenia/Schizoaffective Disorder
- 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