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From the Danish Headache Center, University of Copenhagen, and Department of Neurology, Glostrup University Hospital, Copenhagen, Denmark.
Address correspondence and reprint requests to Dr. L. Bendtsen, Danish Headache Center, University of Copenhagen, and Department of Neurology, Glostrup University Hospital, DK-2600 Glostrup, Copenhagen, Denmark; e-mail: bendtsen{at}dadlnet.dk
Background: The tricyclic antidepressant amitriptyline is the only drug with prophylactic efficacy for chronic tension-type headache. However, amitriptyline is only moderately effective, with headache reduction of approximately 30%, and treatment is often hampered by side effects. Mirtazapine is a relatively new so-called noradrenergic and specific serotonergic antidepressant, which is more specific and therefore generally better tolerated.
Objective: To evaluate the efficacy of mirtazapine.
Methods: Twenty-four nondepressed patients with chronic tension-type headache were included in a randomized, double-blind, placebo-controlled, crossover trial. All patients had tried numerous other treatments. Mirtazapine 15 to 30 mg/day or placebo was each given for 8 weeks separated by a 2-week wash-out period.
Results: Twenty-two patients completed the study. The primary efficacy variable, area-under-the-headache curve (AUC; duration x intensity), was lower during treatment with mirtazapine (843) than during treatment with placebo (1,275) (p = 0.01). Mirtazapine also reduced the secondary efficacy variables headache frequency (p = 0.005), headache duration (p = 0.03), and headache intensity (p = 0.03) and was well tolerated.
Conclusions: Mirtazapine reduced AUC by 34% more than placebo in difficult-to-treat patients. This finding is clinically relevant and may stimulate the development of prophylactic treatments with increased efficacy and fewer side effects for tension-type headache and other types of chronic pain.
Received June 16, 2003. Accepted in final form February 27, 2004.
This article has been cited by other articles:
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 Old and New Drug Therapies for Chronic Headache Journal Watch (General), June 25, 2004; 2004(625): 1 - 1. [Full Text]
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