An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
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.
Inclusion Criteria:

 -  Major depression (according to DSM-IV criteria)

 -  MADRS scores superior to 21

 -  Subjects meeting the International Headache Society criteria for chronic primary
 headache (IHSC-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ICHS, 2003)

 Exclusion Criteria:

 -  Over 50% reduction on MADRS scores during wash-out period

 -  Illicit drug or alcohol dependence

 -  History of multiple allergies or hypersensitivity to duloxetine

 -  History of epilepsy or significant neurological disorder

 -  Significant suicide risk

 -  Pregnancy or lactation

 -  Sexually active female subjects not using an efficient contraceptive method

 -  Significant laboratory abnormalities at baseline

 -  Significant clinical disease

 -  Subjects meeting DSM-IV criteria for somatisation disorder. (300.81) or presenting
 with delusional pain symptoms.