Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2020-02-26

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.

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RECRUITING

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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients shall be provided medication with numeric labels

Study Groups

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Duloxetine Group

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.

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

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

Escitalopram Group

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.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

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

Interventions

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Duloxetine

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

Intervention Type DRUG

Escitalopram

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

Intervention Type DRUG

Other Intervention Names

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DUPREX EXAPRO

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No