A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol
Bipolar Disorders, Manic Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorders focused on measuring risperidone, antipsychotic agents, bipolar disorders, manic episode
Eligibility Criteria
Inclusion Criteria: Meets diagnosis criteria for Bipolar I Disorder - Most Recent Episode Manic (Diagnostic and Statistical Manual of Mental Diseases, 4th edition, (DSM-IV)) meets DSM-IV criteria for a current manic episode hospitalized voluntarily at study initiation history of at least one documented manic or mixed episode prior to study initiation total score of >=20 on the Young Mania Rating Scale (YMRS) and total score of <=20 on the Montgomery Asberg Depression Rating Scale (MADRS) at start of the study Exclusion Criteria: Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling borderline or antisocial personality disorder history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation seizure disorder females who are pregnant or nursing, or those lacking adequate contraception.