Clinical trial NCT02041455: Immune-Pineal Axis Function in Fibromyalgia
Official title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Melatonin
Amitriptylin
Imune-pineal axis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Women 18-65 years old
* Fibromyalgia according to the criteria of the American College of Rheumatology (Wolfe 2010)
* Sign the informed consent
* Patients can take medication for chronic pain ( antidepressants , antiepileptics, for example), since there are at least two months

Exclusion criteria:

* patients who did not understand the Portuguese
* diagnosis of malignancies, severe psychiatric disorders , sleep disorders not related to fibromyalgia (apnea , sleepwalking , restless leg syndrome), Alzheimer's disease or any disease (rheumatologic, neurological, etc.) that can modify the evaluations or outcomes
* alcohol abuse or drug addiction
* patients who are performing acupuncture
* BMI greater than 35 ( BMI = body mass index) .
* Patients with history of allergy to amitriptyline or/and melatonin or any other contraindication for the use of these drugs

Primary outcomes:
measure: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
timeFrame: Baseline, week 6
measure: Change from Baseline in Pain Pressure Threshold (PPT) at week 6
timeFrame: Baseline, week 6
measure: Change from Baseline Brain-derived neurotrophic factor at week 6
timeFrame: Baseline, week 6
Secondary outcomes:
measure: Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6
timeFrame: Baseline, week 6
measure: Change from Baseline of the Pain Catastrophizing Scale at week 6
timeFrame: Baseline; week 6
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Wolnei d Caumo, PhD
role: STUDY_DIRECTOR
References:
citation: de Zanette SA, Vercelino R, Laste G, Rozisky JR, Schwertner A, Machado CB, Xavier F, de Souza IC, Deitos A, Torres IL, Caumo W. Melatonin analgesia is associated with improvement of the descending endogenous pain-modulating system in fibromyalgia: a phase II, randomized, double-dummy, controlled trial. BMC Pharmacol Toxicol. 2014 Jul 23;15:40. doi: 10.1186/2050-6511-15-40.