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Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia (CORTEX)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Duloxetine
Escitalopram
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia treatment, Duloxetine, Escitalopram

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Pakistan Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Duloxetine Group

Escitalopram Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 27, 2018
Last Updated
February 25, 2020
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03487211
Brief Title
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Acronym
CORTEX
Official Title
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia treatment, Duloxetine, Escitalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Participant
Masking Description
Patients shall be provided medication with numeric labels
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Escitalopram Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
DUPREX
Intervention Description
Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
EXAPRO
Intervention Description
Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily
Primary Outcome Measure Information:
Title
Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline
Description
Percentage decrease in FIQ-R from baseline
Time Frame
4,8 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad A Arif, MRCP, FRCP
Organizational Affiliation
Shaheed Zulfiqar Ali Bhutto Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Institute of Medical Sciences
City
Islamabad
State/Province
Islamabad Capital Territory
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19369473
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.
Results Reference
result
PubMed Identifier
20828282
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.
Results Reference
result
PubMed Identifier
21772818
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.
Results Reference
result

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Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

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