The efficacy and safety of flexible dose ranges of risperidone vs. Placebo or divalproex sodium in the treatment of manic or mixed episodes associated with bipolar 1 disorder

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaBehaviors and Mental DisordersEnrollment39% FemaleN/A% WhiteN/A
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-USA-240Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)N/A

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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