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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kraepelin Psiquiatria Clinica
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

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.