drugset / Trial / NCT02451475

Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome

NCT02451475

Phase 1/2 Completed 75 enrolled Mansoura University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2013-02
Primary completion
2014-09
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Amitriptyline Small molecule 25 mg
Comparator Paroxetine Small molecule 25 mg
Comparator Venlafaxine Small molecule 75 mg

Indications