A Single-Center, Double-Blind, Placebo-Controlled Evaluation of Lamotrigine in the Treatment of Obesity in Adults.
J Clin Psychiatry 2006;67(2):258-262
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: Unlike many
pharmacotherapies for mood disorders, lamotrigine has not
been shown to be associated with weight gain. This study evaluated the safety and efficacy of
lamotrigine, compared with placebo, as a
monotherapy for weight loss in obese adult subjects.
Method: Forty subjects were randomly
assigned (1:1) to receive lamotrigine 200 mg/day
or placebo for up to 26 weeks. Eligibility included
a body mass index (BMI) of 30 to < 40. The primary endpoint was the change from baseline
to endpoint (week 26) in subject weight. Secondary endpoints included the change from baseline
to endpoint in BMI, percent body fat, serum lipid, and glycosylated hemoglobin values, subject
satisfaction with treatment, and quality of life.
Results: Mean change in body weight
from baseline to endpoint (last observation carried
forward) was -6.4 ± 10.26 lb and -1.2 ± 7.09 lb for lamotrigine and placebo, respectively (p = .0623). Baseline body weight was slightly different
between treatment groups (lamotrigine mean = 207.9 ± 19.88 lb,
placebo mean = 225.0 ± 32.70 lb; p = .0588). There was
a statistically significant difference (p = .0421)
in mean change in BMI from baseline to endpoint
(-1.5 ± 2.78 and -0.1 ± 1.05 for lamotrigine and
placebo, respectively). Subjects were more
satisfied with lamotrigine treatment compared with
placebo (p = .0065). There were no significant
differences between treatment groups in other
secondary endpoints. The most frequently reported adverse event was mild-to-moderate
headache, occurring in both treatment groups.
Conclusion: Lamotrigine demonstrated a
statistically significant difference in mean change
in BMI and a trend toward a decrease in body weight and was well tolerated.