Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
NCT ID: NCT00791739
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
66 participants
INTERVENTIONAL
2008-04-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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one arm study
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written, informed consent
* able to understand and comply with the requirements of the study
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Universidad de Granada
OTHER
Responsible Party
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Elena Pita Calandre
Professor of Pharmacology
Principal Investigators
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Elena P Calandre, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Granada
Locations
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Instituto de Neurociencias
Granada, Granada, Spain
Countries
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References
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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.
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.
Related Links
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Web page of the Institute of Neuroscience of the University of Granada
Other Identifiers
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TZD-PGB-2008
Identifier Type: -
Identifier Source: org_study_id