Efficacy and safety of risperidone in the treatment of schizoaffective disorder: Initial results from a large, multicenter surveillance study

Background: An adequate therapy for psychotic disorders needs to be effecti ve against mood as well as psychotic symptoms. Analyses of data from clinic al trials of risperidone in schizophrenia and small open-label studies in m ania suggest that risperidone may have this broad efficacy profile. We pres ent data on a 6-week trial of risperidone for the treatment of schizoaffect ive disorder that was part of a larger, 6-month surveillance study of patie nts with affective disorders. Method: One hundred two patients suffering from schizoaffective disorder (D SM-IV or ICD-10) entered the trial. Inclusion criteria consisted of a curre nt DSM-IV diagnosis of schizoaffective disorder, bipolar type; DSM-IV manic or mixed psychotic episode; and a Young Mania Rating Scale (YMRS) score >7 for a mixed episode (> 20 for a manic episode). Assessments included the Y MRS, the Positive and Negative Syndrome Scale (PANSS), the Hamilton Rating Scale for Depression (HAM-D), the 4-item Clinical Global Impressions (CGI) scale, and the UKU Side Effect Rating Scale subscale for neurologic side ef fects. For patients entering the study, open-label risperidone therapy was added to their existing regimens of mood-stabilizing treatments. Other anti psychotic drugs were not allowed. Results: Ninety-five patients completed the 6-week trial. At week 6, the me an +/- SD dose of risperidone was 4.7 +/- 2.5 mg/day. The mean scores on th e assessment scales at baseline and week 6 (unless otherwise stated) were a s follows: YMRS, 22.7 and 4.7, an improvement of 18.0 points (p < .0001); P ANSS (at baseline and week 4). 74.1 and 54.2, an improvement of 19.9 points (p < .0001); HAM-D, 14.0 and 7.4. an improvement of 6.6 points (p < .0001) ; CGI (at baseline and week 4), 2.6 and 1.7, an improvement of 0.9 points ( p < .0001). At week 4, most patients had shown improvement in symptom sever ity, and 9.3% were completely symptom-free. There were no statistically sig nificant differences between baseline and week 4 in the severity of extrapy ramidal symptoms as measured by the UKU, Risperidone was well tolerated; si de effects were few and generally mild. Conclusion: The results to date with risperidone indicate that it may have both antipsychotic and mood-stabilizing properties. Despite the limitations of the open-label design, the results indicate that risperidone is a safe and effective therapy in combination with mood-stabilizers for the treatmen t of patients with manic, hypomanic, and depressive symptoms of mixed episo des in schizoaffective disorder, bipolar type.