A Study of the Effectiveness and Safety of Risperidone as add-on Therapy to Mood Stabilizers in the Treatment of Manic Episodes Associated With Bipolar Disorder
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: Diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) hospitalized for mania with a score >=20 on the Young Mania Rating Scale (YMRS) (patients with concurrent symptoms of depression are eligible) inpatient for a minimum of the first 4 days of double-blind treatment therapy with lithium or valproate (mood stabilizers) at start of treatment with study medication 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 4 weeks of starting the study seizure disorder requiring medication known sensitivity to risperidone, haloperidol, lithium, valproate or carbamazepine pregnant or nursing females, or those lacking adequate contraception.