NCT01127490

Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

Duloxetine(Cymbalta) for Fibromyalgia: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Duloxetine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. The investigators will then use this information to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (duloxetine) and others do not. Duloxetine affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression. Duloxetine is approved for sale in the United States by the Food and Drug Administration (FDA) for the treatment of fibromyalgia.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Duloxetine	Subjects will be titrated onto Duloxetine over one week by taking 30 mg every day for seven days. Week 2 the subject will begin to take 60 mg per day until the end of the study. If the subject wishes to stop taking Duloxetine, she will be given 30 mg per day for one week for down titration.
PROCEDURE	Skin biopsy	3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand

Timeline

• Start date: 2010-05-05
• Primary completion: 2015-09-09
• Completion: 2015-09-09
• First posted: 2010-05-21
• Last updated: 2020-01-09

Locations

1 site across 1 country: United States