Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

December 1, 2014 updated by: Elena Pita Calandre, Universidad de Granada

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18012
        • Instituto de Neurociencias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one arm study
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
Other Names:
  • Lyrica
  • Deprax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
Time Frame: Baseline, 6, 12, 18 and 24 weeks
Baseline, 6, 12, 18 and 24 weeks

Secondary Outcome Measures

Outcome 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
Time Frame: Baseline, 6, 12, 18, and 24 weeks
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
Time Frame: baseline, 6, 12, 18, and 24 weeks
baseline, 6, 12, 18, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Elena P Calandre, MD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TZD-PGB-2008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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