Study Phase 3

A Randomized, Double-blind, Placebo-controlled Study to Explore the Efficacy and Safety of Risperidone Long-acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder, With Open-label Extension

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL CONSTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment559% Female49%% White80%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRISBIM3003Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)39.2

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


Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.