Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

University of Granada (UGR)

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia

Treatments: Drug: trazodone, pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00791739

TZD-PGB-2008

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

one arm study

Experimental group

Treatment:

Drug: trazodone, pregabalin