Risperidone in the treatment of affective spectrum disorders and schizophrenia: A large, multicenter post-marketing surveillance study

The purpose of this study was to investigate the efficacy and safety of risperidone in the treatment of schizophrenia, bipolar disorder with manic episode(BPD), major depressive disorder with psychotic feature(MDD) and schizoaffective disorder(SAD) and to find the dose most frequently used in clinical practice. The use of risperidone was investigated in an open, multicenter uncontrolled, post-marketing surveillance study in 5157 subjects treated in 149 psychiatric medical centers in Korea. Mood stabilizers and antidepressants were allowed at the clinicians' decision. Risperidone doses were adjusted upwards to a maximum of 8 mg depending on clinical response. Clinical improvements in the BPD, the SAD and the MDD groups were higher than those in the schizophrenia group after 8 weeks' treatment with risperidone. There was no significant difference in the number of side effects across the diagnostic groups. No clinically significant changes in vital signs or laboratory values were noted in any group at endpoint. Risperidone was found to be an effective and well tolerated treatment for patients with manic episode, major depressive disorder with psychotic feature, as well as schizophrenia and schizoaffective disorder in clinical practice.