An 8-Week, Open-Label Trial of Duloxetine for Comorbid Major Depressive Disorder and Chronic Headache
J Clin Psychiatry 2008;69(9):1449-1454
© Copyright 2015 Physicians Postgraduate Press, Inc.
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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
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