Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de Granada
• Treatments: Pregabalin; Trazodone

Criteria

Inclusion Criteria:

• patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria

• written, informed consent

• able to understand and comply with the requirements of the study

Exclusion Criteria:

• pregnancy or breastfeeding

• unwillingness to discontinue other prescribed medications before entering in the study

• patients who had previously received trazodone without improvement or who did not tolerate the drug

• patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)