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

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 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Trazodone Trazodone hydrochloride Pregabalin

U.S. FDA Resources

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 ]


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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:

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

Publications:

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
Study First Received:	November 12, 2008
Last Updated:	December 1, 2014
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)

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

ClinicalTrials.gov processed this record on September 23, 2016