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

NCT ID: NCT00531895

Last Updated: 2007-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Major Depression Chronic Primary Headache

Keywords

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major depression chronic headache antidepressant duloxetine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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duloxetine

duloxetine 60 mg/d

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Kraepelin Psiquiatria Clinica

OTHER

Sponsor Role lead

Principal Investigators

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Fernando M Volpe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital SOCOR

Locations

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Hospital SOCOR

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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. doi: 10.4088/jcp.v69n0912.

Reference Type DERIVED
PMID: 19193344 (View on PubMed)

Other Identifiers

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O021

Identifier Type: -

Identifier Source: org_study_id