An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache - Full Text View

Sponsor:	Kraepelin Psiquiatria Clinica
Collaborator:	Eli Lilly and Company
Information provided by:	Kraepelin Psiquiatria Clinica
ClinicalTrials.gov Identifier:	NCT00531895

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 IV

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:

MedlinePlus related topics: Antidepressants Depression Headache

Drug Information available for: Duloxetine Duloxetine hydrochloride

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:

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):

Volpe FM. An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache. J Clin Psychiatry. 2008 Sep;69(9):1449-54.

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 February 13, 2012