Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: trazodone, pregabalin	Phase 4

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Deprax; Lyrica

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
Instituto de Neurociencias
Granada, Spain, 18012

Sponsors and Collaborators

Universidad de Granada

Investigators

Principal Investigator:	Elena P Calandre, MD	Universidad de Granada

More Information

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Additional Information:

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

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Calandre EP, Morillas-Arques P, Molina-Barea R, Rodriguez-Lopez CM, Rico-Villademoros F. Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study. BMC Musculoskelet Disord. 2011 May 16;12:95. doi: 10.1186/1471-2474-12-95.

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
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