Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Study Overview
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Brief Summary
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Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a treatment modality for Fibromyalgia is limited, however small trials have demonstrated its efficacy. No head to head comparisons between escitalopram and duloxetine have been undertaken. We aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed Fibromyalgia.

Detailed Description
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180 drug naive patients with newly diagnosed fibromyalga according to the modified ACR 2016 criteria shall be enrolled by consecutive sampling after taking written informed consent. Baseline severity of fibromyalgia shall be assessed via the Revised Fibromyalgia Impact Questionnaire (FIQ-R). They shall be randomized via cluster randomization into two groups. The first group shall receive Duloxetine 30mg, will be increased to 60mg after one week. The second group shall receive Escitalopram 10mg to be increased to 20mg after one week. Patients shall be followed at 0,2,4,8 and 12 weeks. At each visit, any subjective change in symptoms shall be noted and the FIQ-R shall be re administered. At the end of the trial, the overall change in the FIQ-R from baseline shall be assessed and the difference between both groups will be analyzed.

Official Title
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Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug Naive patients Newly diagnosed with FIbromyalgia according to Modified ACR 2016 criteria Exclusion Criteria: Concomitant depression/bipolar disorder or any other documented psychiatric illness Autoimmune disorders (SLE, RA) Peripheral Neuropathic pain due to any cause Uncontrolled hypertension Impaired renal or hepatic functions (on Lab assay) Chronic infections (e.g.Tuberculosis)

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duloxetine Group<br>Duloxetine 30mg once daily to be started for 1 week. Dose will then be titrated to 60mg once daily and the patients followed for a total of 12 weeks. | Drug: Duloxetine<br>* Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily<br>* Other names: DUPREX;|
| Experimental: Escitalopram Group<br>Escitalopram 10mg once daily to be started for 1 week. Dose will then be titrated to 20mg once daily and the patients followed for a total of 12 weeks. | Drug: Escitalopram<br>* Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily<br>* Other names: EXAPRO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline | Percentage decrease in FIQ-R from baseline | 4,8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia treatment, Duloxetine, Escitalopram