Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
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ClinicalTrials.gov Identifier: NCT00791739 |
Recruitment Status
:
Completed
First Posted
: November 14, 2008
Last Update Posted
: December 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Drug: trazodone, pregabalin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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) |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: one arm study |
Drug: trazodone, pregabalin
Other Names:
|
- Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ]
- 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 ]

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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791739
Spain | |
Instituto de Neurociencias | |
Granada, Spain, 18012 |
Principal Investigator: | Elena P Calandre, MD | Universidad de Granada |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Elena Pita Calandre, Professor of Pharmacology, Universidad de Granada |
ClinicalTrials.gov Identifier: | NCT00791739 History of Changes |
Other Study ID Numbers: |
TZD-PGB-2008 |
First Posted: | November 14, 2008 Key Record Dates |
Last Update Posted: | December 3, 2014 |
Last Verified: | December 2014 |
Keywords provided by Elena Pita Calandre, Universidad de Granada:
fibromyalgia trazodone pregabalin |
Fibromyalgia Impact Questionnaire (FIQ) Pittsburgh Sleep Quality Inventory (PSQI) Brief Pain Inventory (BPI) |
Additional relevant MeSH terms:
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Pregabalin Trazodone Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents |