A Preliminary Open-Label Study of Zonisamide Treatment for Bipolar Depression in 10 Patients
J Clin Psychiatry 2005;66(2):195-198
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: The purpose of this study was to
investigate the effectiveness of zonisamide in the treatment of
Method: Ten patients with DSM-IV bipolar
disorder, depressed phase, who had either not tolerated or not
responded to previous treatments were given zonisamide in this
add-on open-label study. Zonisamide treatment was started at 100
mg/day and increased by 100 mg every 2 weeks to a maximum of 300
mg/day in divided doses (b.i.d. or t.i.d.). Subjects underwent
weekly visits at which they were administered the 17-item
Hamilton Rating Scale for Depression (HAM-D), Young Mania Rating
Scale (YMRS), and Clinical Global Impressions scale (CGI). Every
2 weeks, subjects also underwent laboratory tests, a urine
examination, and a verbal memory test. Outcome measures were
analyzed with repeated-measures analysis of variance.
Results: Eight subjects completed all 8
weeks of the study. Two subjects completed more than 4 weeks of
the study, and their data were analyzed using the last
observation carried forward. Bipolar depression subjects had a
significant reduction in HAM-D scores (p < .001) and in
CGI-Improvement (CGI-I) scores (p < .001). Five of 8 subjects
who completed all 8 weeks of the study had more than a 50%
decrease in HAM-D scores and were rated much improved on the
CGI-I at the end of 8 weeks of treatment. There was no
significant drug effect on YMRS scores, weight, or verbal memory.
Conclusion: Zonisamide may be a useful
drug in the treatment of bipolar depression. Further controlled
clinical trials are needed.