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

Phase 4

Completed

• Conditions: Major Depression; Chronic Primary Headache

• Registration Number: NCT00531895
• Lead Sponsor: Kraepelin Psiquiatria Clinica

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study Completion: 2007-03
• Status Verified: 2007-08
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Last Update Submitted: 2007-09-18
• Study First Posted: 2007-09-19
• Last Update Posted: 2007-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Montgomery-Äsberg Depression Scale (MADRS)	8 weeks
Visual Analog Scale for pain (VAS)	8 weeks

Secondary Outcome Measures

Name	Time	Method
WHO Quality of Life Scale (WHOQOL BREF)	8 weeks

Trial Locations

Locations (1)

Hospital SOCOR; 🇧🇷 Belo Horizonte, MG, Brazil