Ignite Creation Date:
2024-05-05 @ 9:34 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00919295
Status:
COMPLETED
Last Update Posted:
2012-07-25
First Post:
2009-06-11
Brief Title:
Study of Indoleamine 23-dioxygenase Activity Serum Levels of Cytokines BDNF BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Study of Anti-nociceptive Biogenic Amine Status Indoleamine 23-dioxygenase Activity Serum Levels of Cytokines BDNF BH4 and Mirtazapine Efficacy in Thai Fibromyalgia Syndrome Patients
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 23-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 andor 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 N111 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 andor 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
1 Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control
2 Higher IDO activity could be observed in FMS patients
3 Higher cytokines could be observed in FMS patients
4 Higher BDNF could be observed in FMS patients
5 Lower BH4 could be observed in FMS patients
6 Mirtazapine is effective in FMS treatment
The study will be divided into three parts In part I FMS patients of Thai ethnicity will be examined to determine the blood andor 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 N111 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 andor 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
1 Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control
2 Higher IDO activity could be observed in FMS patients
3 Higher cytokines could be observed in FMS patients
4 Higher BDNF could be observed in FMS patients
5 Lower BH4 could be observed in FMS patients
6 Mirtazapine is effective in FMS treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None