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

Primary Purpose

Major Depression, Chronic Primary Headache

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
duloxetine
Sponsored by
Kraepelin Psiquiatria Clinica
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring major depression, chronic headache, antidepressant, duloxetine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital SOCOR

Outcomes

Primary Outcome Measures

Montgomery-Äsberg Depression Scale (MADRS)
Visual Analog Scale for pain (VAS)

Secondary Outcome Measures

WHO Quality of Life Scale (WHOQOL BREF)

Full Information

First Posted
September 18, 2007
Last Updated
September 18, 2007
Sponsor
Kraepelin Psiquiatria Clinica
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00531895
Brief Title
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Official Title
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kraepelin Psiquiatria Clinica
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Chronic Primary Headache
Keywords
major depression, chronic headache, antidepressant, duloxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
duloxetine 60 mg/d
Primary Outcome Measure Information:
Title
Montgomery-Äsberg Depression Scale (MADRS)
Time Frame
8 weeks
Title
Visual Analog Scale for pain (VAS)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
WHO Quality of Life Scale (WHOQOL BREF)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando M Volpe, MD, PhD
Organizational Affiliation
Hospital SOCOR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital SOCOR
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30000-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19193344
Citation
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.
Results Reference
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An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

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