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OpenTrials
Completed

NCT Number: NCT00531895

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.

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Key information

Conditions

Major Depression Brain Diseases Central Nervous System Diseases Chronic Primary Headache Depressive Disorder Depressive Disorder, Major Headache Disorders Mental Disorders Mood Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital SOCOR

Belo Horizonte, Minas Gerais, 30000-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

duloxetine 60 mg/d

Other names: Cymbalta

Primary outcomes

  1. Montgomery-Äsberg Depression Scale (MADRS)

    Time frame: 8 weeks

  2. Visual Analog Scale for pain (VAS)

    Time frame: 8 weeks

Secondary outcomes

  1. WHO Quality of Life Scale (WHOQOL BREF)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Kraepelin Psiquiatria Clinica

Other

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Sep 19, 2007
Registry last updated
Sep 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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