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Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

This study has been completed.
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada Identifier:
First received: November 12, 2008
Last updated: December 1, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Drug: trazodone, pregabalin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 66
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Deprax
  • Lyrica


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00791739

Instituto de Neurociencias
Granada, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
Principal Investigator: Elena P Calandre, MD Universidad de Granada
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elena Pita Calandre, Professor of Pharmacology, Universidad de Granada Identifier: NCT00791739     History of Changes
Other Study ID Numbers: TZD-PGB-2008
Study First Received: November 12, 2008
Last Updated: December 1, 2014

Keywords provided by Universidad de Granada:
Fibromyalgia Impact Questionnaire (FIQ)
Pittsburgh Sleep Quality Inventory (PSQI)
Brief Pain Inventory (BPI)

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers processed this record on May 23, 2017