Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT00919295
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00919295
Study Brief:
Protocol Section:
NCT00919295