Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
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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.
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ]
Secondary Outcome Measures
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 [ Time Frame: 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 [ Time Frame: baseline, 6, 12, 18, and 24 weeks ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)