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

Tracking Information

First Received Date ^ICMJE

September 18, 2007

Last Updated Date

September 18, 2007

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Major Depression
Chronic Primary Headache

Intervention ^ICMJE

Drug: duloxetine

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00531895

Responsible Party

Study ID Numbers ^ICMJE

O021

Study Sponsor ^ICMJE

Kraepelin Psiquiatria Clinica

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Fernando M Volpe, MD, PhD

Hospital SOCOR

Information Provided By

Kraepelin Psiquiatria Clinica

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP