Antimanic Efficacy of Topiramate in 11 Patients in an Open Trial With an On-Off-On Design
J Clin Psychiatry 2001;62:464-468
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: A series of open studies suggests
that topiramate has efficacy in bipolar disorder. To further
investigate the potential value of topiramate as an antimanic
agent, we conducted an open trial in 11 manic patients.
Method: Eleven patients with bipolar I disorder
with an acute manic episode (DSM-IV) were treated with a mood
stabilizer and/or antipsychotics in sufficient and fixed doses.
All had a Young Mania Rating Scale (YMRS) score of at least 24
(mean ± SD = 33.5 ± 8.1). Topiramate was added after stable
plasma levels of concomitant mood stabilizers had been reached
and was titrated within 1 week to a final dose in the range of 25
to 200 mg/day, depending on clinical efficacy and tolerability.
Topiramate was discontinued after 10 days, while concomitant
medication remained unchanged. After 5 days, topiramate was
reintroduced at similar or increased dosages for another 7 days.
Patients were assessed with the YMRS; the Clinical Global
Impressions scale version for bipolar patients; and the 21-item
Hamilton Rating Scale for Depression.
Results: Seven of the 11 patients
initially showed a good antimanic response with > 50%
reduction in YMRS score. One patient showed psychotic features
following rapid increase in topiramate dosage and dropped out on
day 10. After discontinuation of topiramate, 7 of the remaining
10 patients worsened (increase of >= 25% in YMRS score), 2
remained stable, and 1 discontinued follow-up after good
recovery. After reintroducing topiramate, all patients improved
again within a week, with 8 of 9 meeting the responder criterion
of >= 50% YMRS score reduction when comparing baseline values
with those of day 22. With the exception of the patient who
developed psychosis, topiramate was well tolerated. Concomitant
medication did not interfere with plasma levels of drug, except
for carbamazepine level in 1 patient.
Conclusion: The antimanic response among
patients in this study appears reproducibly linked to the
addition of topiramate.