Clinical trial NCT03487211: Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Official title: Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Keywords: Fibromyalgia treatment
Duloxetine
Escitalopram
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline
timeFrame: 4,8 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Institute of Medical Sciences
state: Islamabad Capital Territory
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Mohammad A Arif, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.