Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Universidad de Granada66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia

Interventions

trazodone, pregabalinDRUG

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Instituto de Neurociencias

Granada, Granada, Spain

Outcomes

Primary Outcomes

Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire

Time frame: Baseline, 6, 12, 18 and 24 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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