NCT03487211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

March 27, 2018

Last Update Submit

February 25, 2020

Conditions

Fibromyalgia

Keywords

Fibromyalgia treatmentDuloxetineEscitalopram

Outcome Measures

Primary Outcomes (1)

  • Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline

    Percentage decrease in FIQ-R from baseline

    4,8 and 12 weeks

Study Arms (2)

Duloxetine Group

ACTIVE COMPARATOR

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.

Drug: Duloxetine

Escitalopram Group

EXPERIMENTAL

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.

Drug: Escitalopram

Interventions

DuloxetineDRUG

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

Also known as: DUPREX
Duloxetine Group
EscitalopramDRUG

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

Also known as: EXAPRO
Escitalopram Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Drug Naive patients
  • Newly diagnosed with FIbromyalgia according to Modified ACR 2016 criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Islamabad, 44000, Pakistan

Location

Related 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.

    PMID: 19369473RESULT

  • 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.

    PMID: 20828282RESULT

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

    PMID: 21772818RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine HydrochlorideEscitalopram

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mohammad A Arif, MRCP, FRCP

    Shaheed Zulfiqar Ali Bhutto Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients shall be provided medication with numeric labels
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

April 9, 2018

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)