A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.
Bipolar Disorder, Manic Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring risperidone, antipsychotic agents, bipolar disorders, manic episode
Eligibility Criteria
Inclusion Criteria: Patients hospitalized for mania with a score >=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible) diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication patients medically stable on the basis of physical examination, medical history and electrocardiogram results. Exclusion Criteria: Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence) history of alcohol or drug abuse or dependence within 3 months of starting the study seizure disorder requiring medication known sensitivity to risperidone, lithium, valproate or carbamazepine pregnant or nursing females, or those lacking adequate contraception.