Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

Study Overview
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Brief Summary
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Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.

Detailed Description
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Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.

Official Title
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Duloxetine (Cymbalta): for Fibromyalgia: An Open Label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therpeutic Responsiveness to Duloxetine.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment Arm Fibromyalgia Diagnosis Female Over the age of 18, under the age of 70 Understands English Not Pregnant/planning to become pregnant Exclusion Criteria: No major psychiatric disorders No major unconrolled systemic diseases which may require hospitalization in the next 6 months Pregnant Inclusion Criteria: Control Arm Female Over the age of 18, under the age of 70 Understands English Not Pregnant/planning to become pregnant Exclusion Criteria: Control Arm No major psychiatric disorders No major unconrolled systemic diseases which may require hospitalization in the next 6 months Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control subjects undergo a skin biopsy. | |
| Experimental: Treatment<br>Subjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine. | Drug: Duloxetine<br>* oral tablet, 30mg daily for 1 week (titration up) oral tablet, 60mg daily for 8 weeks (treatment) oral tablet, 30mg daily for 1 week (titration down, if needed)<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | Changes in Pain measured by Numeric Pain Rating Scale over time. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Duloxetine, Cymbalta, Pain, Peripheral Nerve, Biopsy, Predictive