Authors: Calabrese JR, et al.; for the Lamictal 605 Study Group.
Title: A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder.
Reference: J Clin Psychiatry 2003;64:1013-24.
Purpose: To assess the efficacy and tolerability of lamotrigine and lithium compared with placebo for the prevention of mood episodes in bipolar disorder.
Study design: Randomized, double-blinded, parallel-group, placebo-controlled, multicenter study. Initial open-label phase of 8–16 weeks.
Follow up: 18 months.
Patients: 463 patients stabilized on open-label treatment (221 lamotrigine, 121 lithium, and 121 placebo).
Treatment: In the open-label phase, lamotrigine was titrated to 100–200 mg/day and added to current therapy, with gradual withdrawal of concomitant drugs. Stabilized patients were randomly assigned lamotrigine 50, 200, or 400 mg/day, lithium 0.8–1.1 mEq/L or placebo.
Results: In terms of time to intervention for any mood episode, lamotrigine and lithium were significantly superior to placebo. Lamotrigine was significantly superior to placebo at prolonging time to intervention for a depressive episode. Lithium was significantly superior to placebo at prolonging time to intervention for a manic or hypomanic episode.

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