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In an initial large 7-week randomized, placebo-controlled trial, lamotrigine (at 50 mg/day and 200 mg/day) was superior to placebo in patients with bipolar I depression (Calabrese et al. 1999). Switch rates (3%–8%) were not significantly different among the three groups. A second large placebo-controlled, parallel-group, flexible-dose trial involving patients with bipolar I and II depression did not find a significant advantage for lamotrigine over placebo (Bowden 2001). However, in a post hoc analysis, lamotrigine was superior to placebo in bipolar I patients. Frye et al. (2000) found lamotrigine superior to placebo in improving depression in a double-blind crossover trial in patients with treatment-refractory rapid-cycling bipolar I and II disorders. Lamotrigine was superior to placebo when added to lithium in an 8-week trial in patients with breakthrough depressive episodes (van der Loos and Nolen 2007). Common side effects of lamotrigine in these studies included headache, nausea, infection, and xerostomia. The risk of serious rash from lamotrigine can be reduced by carefully adhering to Physicians' Desk Reference–recommended titration schedules, but patients should be warned of the risk of rash and the need to report it immediately.

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