Background and Objectives: The authors assessed the effectiveness of olanzapine as an adjunctive treatment in migraine status. Methods: Randomized, double-blind, placebo-controlled study. Subjects consecutively admitted to a day program of tertiary referral (97 women; age: 35.8 ± 11.8 yrs.) were assigned to olanzapine (n = 14, 5-10 mg/day) or placebo (n = 17), added to the standard neurological treatment during 4 days. Primary measures were the change in pain and the return to regular daily activities. Secondary and safety measures were the magnitude of sedation, constipation and glucose level changes. Results: No significant differences were observed in the overall analysis of the primary measures. However, change in pain significantly correlated with age in the olanzapine group (p = 0.03). In the > 40 year-old group, olanzapine (n = 5) displayed a significantly higher reduction in pain than placebo (n = 4) at days 1 (p = 0.048) and 3 (p = 0.045). No significant differences were observed in the change of serum glucose levels. Conclusions: Olanzapine was well tolerated and sedation was welcomed by most subjects. The positive effect in subjects aged > 40 years awaits replication.
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