Major Depression Clinical Trial
Official title:
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Background: Although major depression and chronic headache are strongly associated, there is
insufficient evidence on the use of antidepressants for this specific comorbidity. This
trial aimed to investigate the efficiency and tolerability of duloxetine for this
indication.
Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent
primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55
years, were recruited from April 2006 to March 2007, if they scored >21 on the
Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition.
Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain
scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF)
scores and headache days/week were secondary outcome measures.Conclusion: In this
preliminary open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated
for the treatment of comorbid major depression and chronic headache.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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