Authors: Goodwin GM, et al. Title: A pooled analysis of two placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder. Reference:J Clin Psychiatry 2004;65:432-41. Purpose: To determine the time to intervention for a mood episode with lamotrigine, lithium, or placebo in recently depressed or manic patients. Study design: Combined analysis of two randomized, double-blinded, clinical trials of lamotrigine or placebo as monotherapy. Follow up: 18 months. Patients: 1,315 bipolar patients were included in the open-label phase and 638 patients were randomized to 18 months of double-blinded therapy (280 lamotrigine, 167 lithium, 191 placebo). Treatment: Lamotrigine 50–400 mg/day, lithium 0.8–1.1 mEq/L, or placebo. Results: Lamotrigine and lithium were superior to placebo for time to intervention for any mood episode. Lamotrigine was superior to placebo for time to intervention for depression, both drugs were superior to placebo for time to intervention to mania, and lithium was superior to lamotrigine for mania. There was a greater incidence of diarrhea and tremor in lithium-treated patients compared with lamotrigine-treated patients.
