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Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome

NCT02451475 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-05-22

No results posted yet for this study

Summary

Background: The investigator hypothesized that the combined use of pregabalin and paroxetine would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and higher tolerability than amitriptyline or venlafaxine.

Methods: After ethical approval, 75 patients with diagnosed fibromyalgia who were receiving pregabalin 75 mg/day, were randomly allocated to receive amitriptyline 25 mg/day (n = 24), venlafaxine 75 mg/day (n = 25), or paroxetine 25 mg/day (n = 26). All patients were assessed bi-monthly for consequent six months for the changes in the SSS-8, Center for Epidemiological Studies Depression Scale (CESDS), life satisfaction, mood, sleep quality, fatigue and medication tolerability and adverse effects.

Conditions

  • Fibromyalgia

Interventions

DRUG

Amitriptyline

Amitriptyline 25 mg/day

DRUG

Venlafaxine

Venlafaxine 75 mg/day

DRUG

Paroxetine

Paroxetine 25 mg/day

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Eiad Ramzy, MD · Lecturer of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-09-30
Completion
2014-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451475 on ClinicalTrials.gov