Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: trazodone, pregabalin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm study<br> | Drug: trazodone, pregabalin<br>* 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<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire |  | Baseline, 6, 12, 18 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, trazodone, pregabalin, Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Inventory (PSQI), Brief Pain Inventory (BPI)