Adjunctive Topiramate Therapy in Patients Receiving a Mood Stabilizer for Bipolar I Disorder: A Randomized, Placebo-Controlled Trial
J Clin Psychiatry 2006;67(11):1698-1706
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: To investigate the efficacy
and safety of topiramate versus placebo as
adjunctive therapy for the outpatient management of
bipolar I disorder.
Method: In this 12-week, randomized,
double-blind, placebo-controlled trial, adults with
bipolar I disorder (DSM-IV criteria) experiencing
a manic or mixed episode with a Young Mania Rating Scale (YMRS) score of >= 18 while
taking therapeutic levels of valproate or lithium
received adjunctive topiramate or placebo. Topiramate
was titrated from 25 to 400 mg/day over 8 weeks
and was continued for 4 additional weeks. The
study was conducted from October 2001 through October 2003. The primary outcome measure was
the change in YMRS score from baseline to last
study visit during the double-blind phase.
Results: The mean ± SD change in
YMRS score from baseline was -10.1 ± 8.7 (-40.1%)
in the topiramate group (N = 143) and -9.6 ± 8.2
(-40.2%) in the placebo group (N = 144, p = .797). Greater than 50% reduction in YMRS
was achieved by 39% of the topiramate group and 38% of the placebo group (p = .914). No
significant treatment differences were observed for
secondary efficacy measures. Compared with adjunctive placebo, adjunctive topiramate did
not worsen mania or induce depression.
Paresthesia, diarrhea, and anorexia were more common in
the topiramate group. The topiramate group
achieved greater reductions than the placebo group in
body weight (-2.5 vs. 0.2 kg, p < .001) and body
mass index (-0.84 vs. 0.07 kg/m2, p < .001).
Conclusion: In patients treated with lithium
or valproate, there was no difference in the
reduction of YMRS score in the topiramate and
placebo groups. Both groups showed declines of
40%. Topiramate reduced body weight significantly relative to placebo without worsening
depressive or manic symptoms.