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Sponsors and Collaborators: |
Kraepelin Psiquiatria Clinica Eli Lilly and Company |
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Information provided by: | Kraepelin Psiquiatria Clinica |
ClinicalTrials.gov Identifier: | NCT00531895 |
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 |
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Major Depression Chronic Primary Headache |
Drug: duloxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache |
Enrollment: | 30 |
Study Start Date: | April 2006 |
Study Completion Date: | March 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, mg | |
Hospital SOCOR | |
Belo Horizonte, mg, Brazil, 30000-000 |
Principal Investigator: | Fernando M Volpe, MD, PhD | Hospital SOCOR |
Study ID Numbers: | O021 |
Study First Received: | September 18, 2007 |
Last Updated: | September 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00531895 |
Health Authority: | Brazil: National Committee of Ethics in Research |
major depression chronic headache antidepressant duloxetine |
Depression Central Nervous System Diseases Pain Depressive Disorder, Major Depressive Disorder Brain Diseases Serotonin Duloxetine |
Headache Disorders Behavioral Symptoms Signs and Symptoms Dopamine Mental Disorders Headache Mood Disorders Neurologic Manifestations |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Nervous System Diseases Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |