Immune-Pineal Axis Function in Fibromyalgia

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: Melatonin and Amitriptylin; Drug: Amitriptyline and Placebo; Drug: Melatonin and Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02041455

09-261

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 3 patient groups

Melatonin and Placebo

Experimental group

Description:

Melatonin 10mg and placebo, once in the evening, for 6 weeks.

Treatment:

Drug: Melatonin and Placebo

Amitriptyline and placebo

Experimental group

Description:

Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.

Treatment:

Drug: Amitriptyline and Placebo

Melatonin and Amitriptylin

Active Comparator group

Description:

Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.

Treatment:

Drug: Melatonin and Amitriptylin