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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Kraepelin Psiquiatria Clinica
ClinicalTrials.gov Identifier:
NCT00531895
First received: September 18, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

September 18, 2007
September 18, 2007
April 2006
Not Provided
  • Montgomery-Äsberg Depression Scale (MADRS) [ Time Frame: 8 weeks ]
  • Visual Analog Scale for pain (VAS) [ Time Frame: 8 weeks ]
Same as current
No Changes Posted
WHO Quality of Life Scale (WHOQOL BREF) [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Major Depression
  • Chronic Primary Headache
Drug: duloxetine
duloxetine 60 mg/d
Other Name: Cymbalta
Not Provided
Volpe FM. An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache. J Clin Psychiatry. 2008 Sep;69(9):1449-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2007
Not Provided

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00531895
O021
No
Not Provided
Kraepelin Psiquiatria Clinica
Eli Lilly and Company
Principal Investigator: Fernando M Volpe, MD, PhD Hospital SOCOR
Kraepelin Psiquiatria Clinica
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP