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

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depression, Chronic Primary Headache

Intervention / Treatment
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* Drug: duloxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine|duloxetine 60 mg/d|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Äsberg Depression Scale (MADRS) |  | 8 weeks | 
| Visual Analog Scale for pain (VAS) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Quality of Life Scale (WHOQOL BREF) |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depression, chronic headache, antidepressant, duloxetine