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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531895
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : September 19, 2007
Eli Lilly and Company
Information provided by:
Kraepelin Psiquiatria Clinica

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Chronic Primary Headache Drug: duloxetine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Study Start Date : April 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Intervention Details:
  • Drug: duloxetine
    duloxetine 60 mg/d
    Other Name: Cymbalta

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00531895

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Hospital SOCOR
Belo Horizonte, MG, Brazil, 30000-000
Sponsors and Collaborators
Kraepelin Psiquiatria Clinica
Eli Lilly and Company
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Principal Investigator: Fernando M Volpe, MD, PhD Hospital SOCOR
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00531895    
Other Study ID Numbers: O021
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: September 19, 2007
Last Verified: August 2007
Keywords provided by Kraepelin Psiquiatria Clinica:
major depression
chronic headache
Additional relevant MeSH terms:
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Headache Disorders
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents