Study Phase 3

The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Or Mixed Episodes Associated With Bipolar I Disorder

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaBehaviors and Mental DisordersEnrollment291% Female37%% WhiteN/A
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-IND-2/CR006064Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)35

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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