Efficacy and Safety of Risperidone in the Treatment of Schizoaffective Disorder: Initial Results From a Large, Multicenter Surveillance Study
J Clin Psychiatry 2001;62(8):623-630
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: An adequate therapy for psychotic
disorders needs to be effective against mood as well as psychotic
symptoms. Analyses of data from clinical trials of risperidone in
schizophrenia and small open-label studies in mania suggest that
risperidone may have this broad efficacy profile. We present data
on a 6-week trial of risperidone for the treatment of
schizoaffective disorder that was part of a larger, 6-month
surveillance study of patients with affective disorders.
Method: One hundred two patients suffering from
schizoaffective disorder (DSM-IV or ICD-10) entered the trial.
Inclusion criteria consisted of a current 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 YMRS, 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 effects.
For patients entering the study, open-label risperidone therapy
was added to their existing regimens of mood-stabilizing
treatments. Other antipsychotic drugs were not allowed.
Results: Ninety-five patients completed the
6-week trial. At week 6, the mean ± SD dose of risperidone was
4.7 ± 2.5 mg/day. The mean scores on the assessment scales at
baseline and week 6 (unless otherwise stated) were as follows:
YMRS, 22.7 and 4.7, an improvement of 18.0 points (p < .0001);
PANSS (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 severity, and 9.3%
were completely symptom-free. There were no statistically
significant differences between baseline and week 4 in the
severity of extrapyramidal symptoms as measured by the UKU.
Risperidone was well tolerated; side effects were few and
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 treatment of patients with manic, hypomanic, and depressive symptoms of mixed episodes in schizoaffective disorder, bipolar type.