drugset / Trial / NCT02041455

Immune-Pineal Axis Function in Fibromyalgia

NCT02041455

Phase 2/3 Unknown 66 enrolled Hospital de Clinicas de Porto Alegre
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2010-06
Primary completion
2014-01
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Amitriptyline Small molecule 25 mg
Subject Melatonin Small molecule 10 mg

Indications