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)

Universidad de Granada1 site in 1 country66 target enrollmentApril 2008

ConditionsFibromyalgia

Interventionstrazodone, pregabalin

Drugstrazodone, pregabalin

Overview

Phase: Phase 4
Intervention: trazodone, pregabalin
Conditions: Fibromyalgia
Sponsor: Universidad de Granada
Enrollment: 66
Locations: 1
Primary Endpoint: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

October 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universidad de Granada

Responsible Party

Principal Investigator

Elena Pita Calandre

Professor of Pharmacology

Universidad de Granada

Eligibility Criteria

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)

Arms & Interventions

one arm study

Intervention: trazodone, pregabalin

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(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)