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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Kraepelin Psiquiatria Clinica
ClinicalTrials.gov Identifier:
NCT00531895
First received: September 18, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531895

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

No publications provided by Kraepelin Psiquiatria Clinica

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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
antidepressant
duloxetine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Headache
Depressive Disorder, Major
Headache Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Duloxetine
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013