1-Year Follow-Up of Patients Treated With Risperidone and Topiramate for a Manic Episode
J Clin Psychiatry 2003;64:834-839
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: The safety and efficacy of the
combination of risperidone and topiramate in the long-term
treatment of mania were assessed in a 12-month, multicenter open
Method: Subjects (N = 58) who met DSM-IV
criteria for bipolar disorder and for a manic episode received
both risperidone and topiramate for the treatment of their manic
symptoms. Patients with mixed episodes were excluded. Risperidone
could be discontinued at any point, but patients had to be on
topiramate therapy for at least 12 months to be considered
completers. Efficacy was assessed with the Young Mania Rating
Scale (YMRS) and a modified version of the Clinical Global
Impressions for Bipolar Disorder (CGI-BP-M). Safety was assessed
with systematic collection of side effect data, weight, and the
Hamilton Rating Scale for Depression (HAM-D) scores, to address
the risk of switch into depression.
Results: 41 patients (70.7%) completed the
study. There was a significant improvement on the YMRS (p <
.001) and the CGI-BP-M subscales for manic symptoms (p < .005)
and long-term outcome (p < .005) from week 2 onward. Relapse
rates were significantly lower during the 12-month study period
compared to the precedent year (p < .0001). There was no
increase in depressive symptoms as measured by the HAM-D. 37
patients (63.8%) experienced at least 1 adverse event, the most
frequent of which was somnolence (N = 7, 12.1%). At endpoint, the
patients' mean weight had decreased an average of 1.1 ± 0.4 kg.
Conclusion: Despite the limitations
inherent to the open design, this naturalistic study suggests
that the combination of risperidone and topiramate may be a
valuable option for the short- and long-term treatment of mania.