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

NCT00531895 | Completed Phase 4

• 1 other identifier: O021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Chronic Primary Headache

Keywords

major depression; chronic headache; antidepressant; duloxetine

Outcome Measures

Primary Outcomes (2)

• Montgomery-Äsberg Depression Scale (MADRS)

  8 weeks

• Visual Analog Scale for pain (VAS)

  8 weeks

Secondary Outcomes (1)

• WHO Quality of Life Scale (WHOQOL BREF)

  8 weeks

Interventions

duloxetine DRUG

duloxetine 60 mg/d

Also known as: Cymbalta

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kraepelin Psiquiatria Clinica: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Hospital SOCOR

Belo Horizonte, Minas Gerais, 30000-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 19193344 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Headache Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fernando M Volpe, MD, PhD

  Hospital SOCOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: April 1, 2006
• Study Completion: March 1, 2007
• Last Updated: September 19, 2007

Record last verified: 2007-08

Locations

BR (1)