A Phase 2/3 interventional study of Melatonin and Placebo and Amitriptyline and Placebo in Fibromyalgia, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 2/3, Interventional, and Treatment
Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .
Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .
The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.
The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Melatonin 10mg and placebo, once in the evening, for 6 weeks.
Drug: Melatonin and Placebo
Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.
Drug: Amitriptyline and Placebo
Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.
Drug: Melatonin and Amitriptylin
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Time frame: Baseline, week 6
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
Pain Pressure Threshold by Fischer algometer on the tender points.
Time frame: Baseline, week 6
Change from Baseline Brain-derived neurotrophic factor at week 6
Time frame: Baseline, week 6
Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6
Time frame: Baseline, week 6
Change from Baseline of the Pain Catastrophizing Scale at week 6
Catastrophic thinking related to pain
Time frame: Baseline; week 6
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre