Duloxetine Prophylaxis for Episodic Migraine in Persons Without Depression: A Prospective Study


  • Conflict of Interest: Dr. W. Young serves as a consultant for MAP Pharmaceuticals (now Allergan) and Zogenix; received research support from Advanced Neuromodulation Systems, Allergan, Boston Scientific, Cumberland, Electro Core, Eli Lilly, Merck, Optinose, and Troy Healthcare; and receives royalties from Migraine and Other Headaches (2004) published by Demos Medical. K. Bradley reports no conflicts. Dr. M. Anjum reports no conflicts. C. Gebeline-Myers reports no conflicts.

Address all correspondence to W.B. Young, Professor of Neurology and Director, Inpatient Program, Headache Center, Thomas Jefferson University Hospital, 111 South Eleventh Street, Gibbon Building, Suite #8130, Philadelphia, PA 19107, USA, email william.b.young@jefferson.edu



The objective of this pilot study is to evaluate the effects of daily duloxetine, 60-120 mg, on the frequency, duration, and severity of migraine attacks and the level of disability in episodic migraineurs.


There is a need for more proven effective migraine preventive medications. Two antidepressants, both of which block serotonin and norepinephrine reuptake, have been shown to be effective in the preventive treatment of migraine. Neither has earned a level A recommendation in the 2012 guidelines of the American Academy of Neurology. Duloxetine also blocks serotonin and norepinephrine reuptake.


This was a prospective, 5-visit study on duloxetine treatment of episodic migraine headache with 4-10 migraine days, and less than 15 headache days per month. Patients were titrated to a goal dose of 120 mg. They were excluded if they had depression.


There were 22 completers plus 5 subjects who took at least 1 dose of drug. The mean duloxetine dose was 110 mg. In a modified intent-to-treat analysis, subjects went from 9.2 ± 2.7 headache days per month at baseline to 4.5 ± 3.4 headache days per month (P < .001). There were no significant differences in the average headache duration, average headache severity, maximum headache attack severity, and level of functioning. Fifty-two percent of subjects had a 50% or greater improvement in headache days.


Migraine prophylactic treatment with high-dose duloxetine may be effective in a nondepressed individual. The reported treatment response is in line with other commonly used migraine preventives.