Fibromyalgia SyndromePhase 2NCT00919295
Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome
A Phase 2 study testing mirtazapine in people with Fibromyalgia Syndrome, run by Mahidol University at 1 site in Thailand.
Trial 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 cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS) patients compared with a representative Thai population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2008to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: Study of Anti-nociceptive Biogenic Amine Status, Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Thai Fibromyalgia Syndrome Patients.
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 cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS) patients compared with a representative Thai population. The efficacy and the tolerability of mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted.
The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines, cytokines, BDNF and BH4 by comparison with the demographically matched, but unrelated, healthy normal controls (HNC). In part II, the FMS subjects from part I study will be randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be three treatment groups (N=1:1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and placebo given before bedtime. Pill counts at baseline and at follow-up visits will document compliance. Standard outcome instruments (translated and validated in Thai language) will be used at baseline and at each of the follow-up visits. The co-primary outcome variable will be the changes in the pain visual analog scale (PVAS) score and pain responders (>= 30% PVAS reduction). Secondary clinical outcome variables of interest will include depression, insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease status, patient global impression of change, fibromyalgia impact questionnaire (FIQ, quality of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in blood and/or urine with the treatment will be examined as the secondary biochemical measures. In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared. Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and non-depressed FMS patients will be assessed.
Read more
Study hypothesis
- Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control.
- Higher IDO activity could be observed in FMS patients.
- Higher cytokines could be observed in FMS patients.
- Higher BDNF could be observed in FMS patients.
- Lower BH4 could be observed in FMS patients.
- Mirtazapine is effective in FMS treatment.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- mirtazapine, placebo
- Keywords
- Fibromyalgia syndrome, mirtazapine, randomized controlled trial, pilot study
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirtazapineDrug
Also called Remeron
mirtazapine 15 mg or 30 mg tablet daily at bedtime for 13 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
| mirtazapine 15 | Placebo comparator | mirtazapine 15 mg Receives: Drug: mirtazapine |
| mirtazapine 30 | Placebo comparator | mirtazapine 30mg Receives: Drug: mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure for part II of this study will be "change from baseline in the severity of the pain visual analog scale (PVAS) score" and pain responders (>= 30% PVAS reduction).
Measured: day 7, 21, 35, 63, 91 (day 0 = first day of starting expected dose)
Secondary outcomes (1)
Depression, sleep quality, patient global assessment of disease status, FIQ, PGIC, quality of life, adverse events
Measured: day 7, 21, 35, 63, 91 (day 0 = the day of starting expected dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, University of Wuerzburg
- Responsible party
- Principal investigator, Suwimon Yeephu, Mahidol University
- Investigators
- Suwimon Yeephu, Principal investigator, Faculty of Pharmacy Mahidol UniversitySaithip Suttiruksa, Master, Principal investigator, Faculty of Pharmacy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919295
- Sponsor's protocol ID
- 323/2551(EC4)
- Status last verified
- Jul 2012
- First submitted
- 11 Jun 2009
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-nociceptive Biogenic Amine Status, Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Thai Fibromyalgia Syndrome Patients.
- ClinicalTrials.gov ID
- NCT00919295
- Acronym / sponsor ID
- 323/2551(EC4)
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia syndrome, mirtazapine, randomized controlled trial, pilot study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Texas, University of Wuerzburg
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS) patients compared with a representative Thai population. The efficacy and the tolerability of mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted.
The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines, cytokines, BDNF and BH4 by comparison with the demographically matched, but unrelated, healthy normal controls (HNC). In part II, the FMS subjects from part I study will be randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be three treatment groups (N=1:1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and placebo given before bedtime. Pill counts at baseline and at follow-up visits will document compliance. Standard outcome instruments (translated and validated in Thai language) will be used at baseline and at each of the follow-up visits. The co-primary outcome variable will be the changes in the pain visual analog scale (PVAS) score and pain responders (>= 30% PVAS reduction). Secondary clinical outcome variables of interest will include depression, insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease status, patient global impression of change, fibromyalgia impact questionnaire (FIQ, quality of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in blood and/or urine with the treatment will be examined as the secondary biochemical measures. In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared. Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and non-depressed FMS patients will be assessed.
Study hypothesis
- Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control.
- Higher IDO activity could be observed in FMS patients.
- Higher cytokines could be observed in FMS patients.
- Higher BDNF could be observed in FMS patients.
- Lower BH4 could be observed in FMS patients.
- Mirtazapine is effective in FMS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo |
| mirtazapine 15 | Placebo comparator | Drug: mirtazapinemirtazapine 15 mg |
| mirtazapine 30 | Placebo comparator | Drug: mirtazapinemirtazapine 30mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirtazapineAlso: Remeronmirtazapine 15 mg or 30 mg tablet daily at bedtime for 13 weeks | Drug | mirtazapine 15, mirtazapine 30 |
| placeboplacebo | Drug | placebo |
Primary outcome
The primary outcome measure for part II of this study will be "change from baseline in the severity of the pain visual analog scale (PVAS) score" and pain responders (>= 30% PVAS reduction).
Time frame: day 7, 21, 35, 63, 91 (day 0 = first day of starting expected dose)
1 secondary outcome
Depression, sleep quality, patient global assessment of disease status, FIQ, PGIC, quality of life, adverse events
Time frame: day 7, 21, 35, 63, 91 (day 0 = the day of starting expected dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suwimon Yeephu principal investigator
Faculty of Pharmacy Mahidol University
Saithip Suttiruksa, Master principal investigator
Faculty of Pharmacy, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mirtazapine in people with Fibromyalgia Syndrome, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure for part II of this study will be "change from baseline in the severity of the pain visual analog scale (PVAS) score" and pain responders (>= 30% PVAS reduction). (time frame: day 7, 21, 35, 63, 91 (day 0 = first day of starting expected dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012.