Clinical trial NCT00791739: Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: fibromyalgia
trazodone
pregabalin
Fibromyalgia Impact Questionnaire (FIQ)
Pittsburgh Sleep Quality Inventory (PSQI)
Brief Pain Inventory (BPI)
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
timeFrame: Baseline, 6, 12, 18 and 24 weeks
Secondary outcomes:
measure: 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
timeFrame: Baseline, 6, 12, 18, and 24 weeks
measure: Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events
timeFrame: baseline, 6, 12, 18, and 24 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto de Neurociencias
Study officials:
affiliation: Universidad de Granada
name: Elena P Calandre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morillas-Arques P, Rodriguez-Lopez CM, Molina-Barea R, Rico-Villademoros F, Calandre EP. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study. BMC Musculoskelet Disord. 2010 Sep 10;11:204. doi: 10.1186/1471-2474-11-204.
citation: Calandre EP, Morillas-Arques P, Molina-Barea R, Rodriguez-Lopez CM, Rico-Villademoros F. Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study. BMC Musculoskelet Disord. 2011 May 16;12:95. doi: 10.1186/1471-2474-12-95.