Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03487211

Acronym

CORTEX

Enrollment

200

Registered

2018-04-03

Start date

2018-04-09

Completion date

2020-02-26

Last updated

2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia treatment, Duloxetine, Escitalopram

Brief 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.

Interventions

DRUGDuloxetine

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

DRUGEscitalopram

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Patients shall be provided medication with numeric labels

Intervention model description

Randomized Control Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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)

Design outcomes

Primary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026