A 7-Week, Randomized, Double-Blind Trial of Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression

A 7-week acute phase of a randomized, double-blind study compared olanzapine/fluoxetine combination therapy in 205 patients with lamotrigine treatment in 205 patients with bipolar I disorder. Completion rates were similar between treatments. There was a significant difference in the incidence of suicidal & self-injurious behaviour adverse events between the treatments (0.5% in olanzapine/fluoxetine combination versus 3.4% in lamotrigine treatment). Two suicide attempts led to discontinuation in lamotrigine-treated patients & 1 suicide attempt led to discontinuation in an olanzapine/fluoxtine combination-treated patient. (36 refs.)