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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531895
• Other study ID #: O021
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2007
• Last updated: September 18, 2007
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2007
• Source: Kraepelin Psiquiatria Clinica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Primary Headache
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Headache
• Major Depression

Intervention

Drug:
• duloxetine
duloxetine 60 mg/d

Locations

Country	Name	City	State
Brazil	Hospital SOCOR	Belo Horizonte	MG

Sponsors (2)

Lead Sponsor	Collaborator
Kraepelin Psiquiatria Clinica	Eli Lilly and Company

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Äsberg Depression Scale (MADRS)		8 weeks
Primary	Visual Analog Scale for pain (VAS)		8 weeks
Secondary	WHO Quality of Life Scale (WHOQOL BREF)		8 weeks