Skip to main content
OpenTrials
Completed

NCT Number: NCT00791739

Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Neurociencias

Granada, 18012, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

trazodone, pregabalin

Drug
  • 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: Deprax, Lyrica

Primary outcomes

  1. Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire

    Time frame: Baseline, 6, 12, 18 and 24 weeks

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 14, 2008
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.