Study Phase 3

A Prospective, Randomized, Double-blind, Placebo-controlled Study of the Effectiveness and Safety of RISPERDAL CONSTA Augmentation in Adult Patients With Frequently-relapsing Bipolar Disorder

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL CONSTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment275% Female40%% White22.5%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-BIP-302Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)38.4

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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