Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Bipolar Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Mania, Manic, Depressive, Manic Depressive, Bipolar mania, risperidone, adolescents, children
Eligibility Criteria
Inclusion Criteria: Current primary diagnosis of bipolar I disorder, mania or mixed type Aged between 10 and 17 years Young Mania Rating Scale score greater than or equal to 20 at screening and baseline Exclusion Criteria: Known or suspected history of substance dependence Significant risk for suicidal or violent behavior Received electroconvulsive treatment within 4 weeks of baseline Received a depot antipsychotic within 2 treatment cycle before baseline Is unable to swallow medication taken in the form of tablets Has a positive result for a urine drug screen done at baseline Known or suspected seizure disorder Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening Known or suspected history of hypersensitivity or intolerance to risperidone History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent