Risperidone Safety and Efficacy in the Treatment of Bipolar and Schizoaffective Disorders: Results From a 6-Month, Multicenter, Open Study
J Clin Psychiatry 2001;62(10):818-825
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: The goal of this study was to assess
the efficacy and safety of risperidone in bipolar and
Method: 541 patients entered this open,
multicenter, 6-month study. Patients were entered provided that
they fulfilled DSM-IV criteria for bipolar disorder or
schizoaffective disorder, bipolar type, during a manic,
hypomanic, mixed, or depressive episode. Risperidone was added to
any previous mood-stabilizing medication that the patients were
taking. Efficacy was assessed with the Young Mania Rating Scale
(YMRS), the Hamilton Rating Scale for Depression (HAM-D), the
Positive and Negative Syndrome Scale (PANSS), and the Clinical
Global Impressions scale (CGI). Extrapyramidal symptoms (EPS)
were assessed using the UKU Side Effect Rating Scale.
Results: 430 patients completed the study.
Addition of risperidone produced highly significant improvements
(p < .0001) on the YMRS and HAM-D at both 6 weeks and 6 months
and on the CGI and the scales of the PANSS at both 4 weeks and 6
months. There was a significant reduction in UKU total and
subscale scores at 6 months. The mean dose of risperidone was 3.9
mg/day. There was no single case of new-emergent tardive
dyskinesia, and there was a very low incidence of exacerbation of
mania within the first 6 weeks (2%). Adverse events were few and
mostly mild, the most frequent being EPS and weight gain.
Conclusion: This large study provides additional
evidence that risperidone is effective and well tolerated when
combined with mood stabilizers in the treatment of bipolar
disorder and schizoaffective disorder, bipolar type. Previous
concerns about exacerbation of manic symptoms were not confirmed.