Study Phase 3

A Randomized, Double Blind, Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Risperidone Long-acting Injectable (LAI) for the Prevention of Mood Episodes in the Treatment of Subjects With Bipolar I Disorder

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL CONSTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment585% Female52%% White43.4%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRISBMN3001Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)36.1

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


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