Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pakistan Institute of Medical Sciences

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Duloxetine

Drug

Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily

Other names: DUPREX

Escitalopram

Drug

Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily

Other names: EXAPRO

Primary outcomes

Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline

Time frame: 4,8 and 12 weeks

Percentage decrease in FIQ-R from baseline

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Acronym: CORTEX

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Apr 3, 2018
Registry last updated: Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed