An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
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|ClinicalTrials.gov Identifier: NCT00531895|
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : September 19, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression Chronic Primary Headache||Drug: duloxetine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache|
|Study Start Date :||April 2006|
|Actual Study Completion Date :||March 2007|
- Montgomery-Äsberg Depression Scale (MADRS) [ Time Frame: 8 weeks ]
- Visual Analog Scale for pain (VAS) [ Time Frame: 8 weeks ]
- WHO Quality of Life Scale (WHOQOL BREF) [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531895
|Belo Horizonte, MG, Brazil, 30000-000|
|Principal Investigator:||Fernando M Volpe, MD, PhD||Hospital SOCOR|