Study Phase 3

Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaBehaviors and Mental DisordersEnrollment13% Female51%% White77%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-BIM-301Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)13

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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