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Background: Two clinical trials, prospectively designed for combined analysis, compared placebo, lithium, and lamotrigine for treatment of bipolar I disorder in recently depressed or manic patients.

Method: 1315 bipolar I patients (DSM-IV) enrolled in the initial open-label phase, and 638 were stabilized and randomly assigned to 18 months of double-blind monotherapy with lamotrigine (N= 280; 50–400 mg/day fixed dose or 100–400 mg/day flexible dose), lithium (N= 167; serum level of 0.8–1.1 mEq/L), or placebo (N= 191). The primary endpoint was time from randomization to intervention for a mood episode. Data were gathered from August 1997 to August 2001.

Results: Lamotrigine and lithium were superior to placebo for time to intervention for any mood episode (median survival: placebo, 86 days [95% CI= 58 to 121]; lithium, 184 days [95% CI= 119 to not calculable]; lamotrigine, 197 days [95% CI= 144 to 388 …