NCT00791739

Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	trazodone, pregabalin	* phase I (from baseline to week 12): trazodone, in a starting dose of 50 mg at bedtime subsequently adjusted according to drug's efficacy and tolerability * phase II (from week 12 to week 24): addition of pregabalin in a starting dose of 75 mg/day subsequently adjusted according to drug's efficacy and tolerability

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2008-11-14
• Last updated: 2014-12-03

Locations

1 site across 1 country: Spain