Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia (CORTEX)

Shaheed Zulfiqar Ali Bhutto Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: Escitalopram; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03487211

ShaheedZABMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Duloxetine Group

Active Comparator group

Description:

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.

Treatment:

Drug: Duloxetine

Escitalopram Group

Experimental group

Description:

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.

Treatment:

Drug: Escitalopram