drugset / Trial / NCT00791739
Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
NaSingle-groupOpen-labelTreatment
Summary
The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-07
- Completion
- 2009-10
Publications
- Results Morillas-Arques P, Rodriguez-Lopez CM, Molina-Barea R, Rico-Villademoros F, Calandre EP. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study. BMC Musculoskelet Disord. 2010 Sep 10;11:204. doi: 10.1186/1471-2474-11-204.
- Calandre EP, Morillas-Arques P, Molina-Barea R, Rodriguez-Lopez CM, Rico-Villademoros F. Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study. BMC Musculoskelet Disord. 2011 May 16;12:95. doi: 10.1186/1471-2474-12-95.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 75 mg | — |
| Subject | Trazodone | Small molecule | 50 mg | — |