An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Information source: Kraepelin Psiquiatria Clinica
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Chronic Primary Headache
Intervention: duloxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Kraepelin Psiquiatria Clinica Official(s) and/or principal investigator(s):
Fernando M Volpe, MD, PhD, Principal Investigator, Affiliation: Hospital SOCOR
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.
Clinical Details
Official title: An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Montgomery-Äsberg Depression Scale (MADRS)Visual Analog Scale for pain (VAS)
Secondary outcome: WHO Quality of Life Scale (WHOQOL BREF)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Hospital SOCOR, Belo Horizonte, mg 30000-000, Brazil
Additional Information
Starting date: April 2006
Ending date: March 2007
Last updated: September 18, 2007
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