drugset / Trial / NCT02451475
Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitriptyline | Small molecule | 25 mg | — |
| Comparator | Paroxetine | Small molecule | 25 mg | — |
| Comparator | Venlafaxine | Small molecule | 75 mg | — |