Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

— CORTEX  

Official title:

Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487211
• Other study ID #: ShaheedZABMU
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 9, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: February 2020
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Duloxetine
Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily
• Escitalopram
Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily

Locations

Country	Name	City	State
Pakistan	Pakistan Institute of Medical Sciences	Islamabad	Islamabad Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15. — View Citation

Smith HS, Bracken D, Smith JM. Pharmacotherapy for fibromyalgia. Front Pharmacol. 2011 Mar 31;2:17. doi: 10.3389/fphar.2011.00017. eCollection 2011. — View Citation

Wright CL, Mist SD, Ross RL, Jones KD. Duloxetine for the treatment of fibromyalgia. Expert Rev Clin Immunol. 2010 Sep;6(5):745-56. doi: 10.1586/eci.10.64. Review. — View Citation

Outcome

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