Status:
COMPLETED
Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
University of Texas
University of Wuerzburg
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to investigate the anti-nociceptive biogenic amine (serotonin \[5-hydroxytryptamine; 5-HT\], norepinephrine \[NE\], dopamine \[DA\], and their metabolites) status, and serum levels of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for randomized controlled trial:
- male or female outpatients \> 18 years of age, descended from Thai parents
- meet criteria for FMS as defined by the American College of Rheumatology 1990
- have a score of \> 4 on the pain visual analog scale (PVAS) score at screening
- Exclusion Criteria:
- any severe or unstable physical or psychiatric disorder
- inflammation or injury or trauma in the previous month
- substance abuse within the past year
- serious suicide risk
- pregnancy or breastfeeding
- subject has an allergic reactions to mirtazapine or any of its constituents or severe allergic reactions to multiple medications
- comorbid inflammatory rheumatic diseases
- Use of medications or herbal agents with CNS activity
- regular use of analgesics with the exception of acetaminophen up to 2 gram/day
- chronic use of sedatives/hypnotics
- unable to discontinue medications that may affect the study results (all antidepressants, mood stabilizers, antipsychotics, sleep aids such as hypnotics, tranquilizers, sedating antihistamine and benzodiazepines, all analgesics including anticonvulsants, muscle relaxants, stimulant medications such as dextroamphetamine and methylphenidate, any other medications taken by the subject for the treatment of fibromyalgia
- unable to attend the follow-up schedule of the study
- not agree with avoidance or stable maintenance of unconventionalor alternative therapies, such as Thai traditional massage
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00919295
Start Date
December 1 2008
End Date
December 1 2011
Last Update
July 25 2012
Active Locations (1)
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1
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700