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

Kraepelin Psiquiatria Clinica

Status and phase

Completed

Phase 4

Conditions

Chronic Primary Headache

Major Depression

Treatments

Drug: duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00531895

O021

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.