NCT03487211

Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Duloxetine	Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily
DRUG	Escitalopram	Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily

Timeline

• Start date: 2018-04-09
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2018-04-03
• Last updated: 2020-02-27

Locations

1 site across 1 country: Pakistan