Trial | NCT00531895  Report issue

Official Title

An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    duloxetine ...

  • Study Participants

    30
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.
Study Started
Apr 30
2006
Study Completion
Mar 31
2007
Last Update
Sep 19
2007
Estimate

Drug duloxetine

duloxetine 60 mg/d

  • Other names: Cymbalta

Criteria 

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.
No Results Posted