A Double-Blind, Placebo-Controlled, Prophylaxis Study of Lamotrigine in Rapid-Cycling Bipolar Disorder
J Clin Psychiatry 2000;61(11):841-850
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Patients with rapid-cycling bipolar
disorder are often treatment refractory. This study examined
lamotrigine as maintenance monotherapy for rapid-cycling bipolar
Method: Lamotrigine was added to patients'
current psychotropic regimens and titrated to clinical effect
during an open-label treatment phase. Stabilized patients were
tapered off other psychotropics and randomly assigned to
lamotrigine or placebo monotherapy for 6 months. Time to
additional pharmacotherapy for emerging symptoms was the primary
outcome measure. Secondary efficacy measures included survival in
study (time to any premature discontinuation), percentage of
patients stable without relapse for 6 months, and changes in the
Global Assessment Scale and Clinical Global Impressions-Severity
scale. Safety was assessed from adverse event, physical
examination, and laboratory data.
Results: 324 patients with rapid-cycling bipolar
disorder (DSM-IV criteria) received open-label lamotrigine, and
182 patients were randomly assigned to the double-blind
maintenance phase. The difference between the treatment groups in
time to additional pharmacotherapy did not achieve statistical
significance in the overall efficacy population. However,
survival in study was statistically different between the
treatment groups (p = .036). Analyses also indicated a 6-week
difference in median survival time favoring lamotrigine.
Forty-one percent of lamotrigine patients versus 26% of placebo
patients (p = .03) were stable without relapse for 6 months of
monotherapy. Lamotrigine was well tolerated; there were no
treatment-related changes in laboratory parameters, vital signs,
or body weight. No serious rashes occurred.
Conclusion: This was the largest and only
prospective placebo-controlled study of rapid-cycling bipolar
disorder patients to date; results indicate lamotrigine
monotherapy is a useful treatment for some patients with
rapid-cycling bipolar disorder.