Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Antidepressive Agents; Paroxetine; Pregabalin; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Fibromyalgia

• Receiving pregabalin daily

Exclusion Criteria:

• Pathologies mimicking the symptoms of fibromyalgia

• Acute systemic inflammatory diseases

• Infections

• Pregnancy

• Lactating