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An 8-Week, Open-Label Trial of Duloxetine for Comorbid Major Depressive Disorder and Chronic Headache

J Clin Psychiatry 2008;69:1449-1454

Background: Although major depression and chronic headache are strongly associated, there is insufficient evidence for the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficacy and tolerability of duloxetine for this indication.

Method: Thirty outpatients with DSM-IV major depressive disorder and concurrent primary chronic headache (chronic migraine, chronic tension-type headache, or both), 18 to 55 years old, were recruited from April 2006 to March 2007, if they scored > 21 on the Montgomery-Asberg Depression Rating Scale (MADRS) and had no other significant clinical condition. Subjects received duloxetine 60 mg/day for 8 weeks. Scores on the MADRS and a visual analog pain scale (VAS) were the co-primary outcome measures. Scores on the brief version of the World Health Organization Quality of Life scale (WHOQoL-BREF) and number of headache days/week were secondary outcome measures. The study was conducted at the Liaison-Psychiatry Service of SOCOR General Hospital, Belo Horizonte, Brazil.

Results: Mean ± SD MADRS scores decreased significantly from baseline to endpoint (29.5 ± 5.2 to 8.9 ± 8.7 points, p < .001), and mean ± SD VAS scores decreased significantly from 5.8 ± 1.9 to 1.9 ± 2.5 points (p < .001). Combined intent-to-treat response rate (> 50% reduction on MADRS and > 40% on VAS) was 66.7% (20/30). Significant improvements in both headache and depression were evident after the first week. Mean ± SD WHOQoL-BREF scores increased (improved) 18.8 ± 21.9 points (p < .001), and mean ± SD number of headache days/week decreased from 5.2 ± 2.0 to 2.9 ± 2.5 days/week (p < .001). Two subjects discontinued for side effects and 3 for nonadherence.

Conclusion: In this preliminary open trial, duloxetine 60 mg/day was effective, fast acting, and well tolerated for the treatment of comorbid major depressive disorder and chronic headache.

Trial Registration: clinicaltrials.gov Identifier: NCT00531895