Fibromyalgia
Conditions
Keywords
fibromyalgia, trazodone, pregabalin, Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Inventory (PSQI), Brief Pain Inventory (BPI)
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.
Interventions
DRUGtrazodone, 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
Sponsors
Universidad de Granada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire | Baseline, 6, 12, 18 and 24 weeks |
Secondary
| Measure | 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 |
Countries
Spain
Outcome results
None listed