Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
one arm study	trazodone, pregabalin	-

Primary Outcome Measures

Name	Time	Method
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire	Baseline, 6, 12, 18 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression Scale	Baseline, 6, 12, 18, and 24 weeks
Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events	baseline, 6, 12, 18, and 24 weeks

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