Clinical trial NCT00531895: An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Official title: An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Chronic Primary Headache
Keywords: major depression
chronic headache
antidepressant
duloxetine
Lead sponsor: Kraepelin Psiquiatria Clinica
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Montgomery-Äsberg Depression Scale (MADRS)
timeFrame: 8 weeks
measure: Visual Analog Scale for pain (VAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: WHO Quality of Life Scale (WHOQOL BREF)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital SOCOR
state: MG
Study officials:
affiliation: Hospital SOCOR
name: Fernando M Volpe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.4088/jcp.v69n0912.