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

This study has been completed.
Eli Lilly and Company
Information provided by:
Kraepelin Psiquiatria Clinica Identifier:
First received: September 18, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

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.

Condition Intervention Phase
Major Depression
Chronic Primary Headache
Drug: duloxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

Resource links provided by NLM:

Further study details as provided by Kraepelin Psiquiatria Clinica:

Primary Outcome Measures:
  • Montgomery-Äsberg Depression Scale (MADRS) [ Time Frame: 8 weeks ]
  • Visual Analog Scale for pain (VAS) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • WHO Quality of Life Scale (WHOQOL BREF) [ Time Frame: 8 weeks ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: March 2007
Intervention Details:
    Drug: duloxetine
    duloxetine 60 mg/d
    Other Name: Cymbalta

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00531895

Hospital SOCOR
Belo Horizonte, MG, Brazil, 30000-000
Sponsors and Collaborators
Kraepelin Psiquiatria Clinica
Eli Lilly and Company
Principal Investigator: Fernando M Volpe, MD, PhD Hospital SOCOR
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00531895     History of Changes
Other Study ID Numbers: O021 
Study First Received: September 18, 2007
Last Updated: September 18, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Kraepelin Psiquiatria Clinica:
major depression
chronic headache

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Antidepressive Agents
Dopamine Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin and Noradrenaline Reuptake Inhibitors processed this record on May 22, 2016