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

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ClinicalTrials.gov Identifier: NCT03487211
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
DR. MOHAMMAD ALI ARIF, Shaheed Zulfiqar Ali Bhutto Medical University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Duloxetine Drug: Escitalopram Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: Single (Participant)
Masking Description: Patients shall be provided medication with numeric labels
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : December 2, 2018
Estimated Study Completion Date : February 13, 2019


Arm Intervention/treatment
Active Comparator: Duloxetine Group
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
Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily
Other Name: DUPREX

Experimental: Escitalopram Group
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
Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily
Other Name: EXAPRO




Primary Outcome Measures :
  1. Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline [ Time Frame: 4,8 and 12 weeks ]
    Percentage decrease in FIQ-R from baseline



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487211


Contacts
Contact: Mohammad A Arif, MRCP, FRCP +923335123701 mohammad_ali_arif@hotmail.com
Contact: Fibhaa SYED, MRCP, FCPS +923335300002 fibhaasyed@gmail.com

Locations
Pakistan
Pakistan Institute of Medical Sciences Recruiting
Islamabad, Islamabad Capital Territory, Pakistan, 44000
Contact: Rauf Niazi, MRCP, FRCP    +923008544122    niazi62@hotmail.com   
Sponsors and Collaborators
Shaheed Zulfiqar Ali Bhutto Medical University
Investigators
Principal Investigator: Mohammad A Arif, MRCP, FRCP Shaheed Zulfiqar Ali Bhutto Medical University

Publications of Results:
Responsible Party: DR. MOHAMMAD ALI ARIF, Assistant Professor of Medicine, Shaheed Zulfiqar Ali Bhutto Medical University
ClinicalTrials.gov Identifier: NCT03487211     History of Changes
Other Study ID Numbers: ShaheedZABMU
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by DR. MOHAMMAD ALI ARIF, Shaheed Zulfiqar Ali Bhutto Medical University:
Fibromyalgia treatment
Duloxetine
Escitalopram

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics