Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia - Full Text View

Sponsored by:	Universidad de Granada
Information provided by:	Universidad de Granada
ClinicalTrials.gov Identifier:	NCT00791739

Purpose

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
Fibromyalgia	Drug: trazodone, pregabalin	Phase IV

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Pregabalin Trazodone Trazodone hydrochloride BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791739

Contacts

Contact: Elena P. Calandre, MD	+34 958246291	calandre@gmail.com
Contact: Fernando Rico-Villademoros, MD	+34 915428826	fernando.ricovillademoros@gmail.com

Locations

Spain
Instituto de Neurociencias	Recruiting
Granada, Spain, 18012
Sub-Investigator: Piedad Morillas-Arques, MD
Sub-Investigator: Carmen Rodriguez-Lopez, MD
Sub-Investigator: Rocío Molina-Barea, MD
Sub-Investigator: Juan S. Vilchez, MD

Sponsors and Collaborators

Universidad de Granada

Investigators

Principal Investigator:

Elena P Calandre, MD

Universidad de Granada

More Information

Web page of the Institute of Neuroscience of the University of Granada This link exits the ClinicalTrials.gov site

Responsible Party:	Universidad de Granada ( Elena Pita Calandre )
Study ID Numbers:	TZD-PGB-2008
Study First Received:	November 12, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00791739
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by Universidad de Granada:

fibromyalgia
trazodone
pregabalin

Fibromyalgia Impact Questionnaire (FIQ)
Pittsburgh Sleep Quality Inventory (PSQI)
Brief Pain Inventory (BPI)

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia

Trazodone
Pregabalin
Pain
Rheumatic Diseases
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Pharmacologic Actions

Serotonin Agents
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Peripheral Nervous System Agents
Analgesics
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Anticonvulsants
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009