Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791739
• Other study ID #: TZD-PGB-2008
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2008
• Last updated: December 1, 2014
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2014
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• trazodone, 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

Locations

Country	Name	City	State
Spain	Instituto de Neurociencias	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire		Baseline, 6, 12, 18 and 24 weeks	No
Secondary	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	No
Secondary	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	Yes

External Links

•   Web page of the Institute of Neuroscience of the University of Granada