Authors: Bowden CL, et al.; for the Lamictal 606 Study group. Title: A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. Reference: Arch Gen Psychiatry 2003;60:392-400. 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: 175 patients from the open-label phase met stabilization criteria and went on to receive maintenance treatment (59 lamotrigine, 46 lithium, and 70 placebo). Treatment: In the open label-phase, lamotrigine was titrated to 100–200mg/day and added to current therapy, with gradual withdrawal of concomitant drugs. Stabilized patients were randomly assigned to lamotrigine 100–400 mg daily, lithium (0.8–1.1 mEq/L), or placebo. Results: Both lamotrigine and lithium were superior to placebo at prolonging the time to intervention for any mood episode. Lamotrigine was superior to placebo at prolonging the time to a depressive episode, while lithium was superior to placebo at prolonging time to a manic, hypomanic, or mixed episode.
