Immune-Pineal Axis Function in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041455
• Other study ID #: 09-261
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 16, 2014
• Last updated: January 17, 2014
• Start date: June 2010
• Est. completion date: March 2014

Study information

• Verified date: January 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Wolnei Caumo, PhD
• Phone: 555133598083
• Email: caumo[@]cpovo.net
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Melatonin and Placebo

• Amitriptyline and Placebo

• Melatonin and Amitriptylin

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6		Baseline, week 6	No
Primary	Change from Baseline in Pain Pressure Threshold (PPT) at week 6	Pain Pressure Threshold by Fischer algometer on the tender points.	Baseline, week 6	No
Primary	Change from Baseline Brain-derived neurotrophic factor at week 6		Baseline, week 6	No
Secondary	Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6		Baseline, week 6	No
Secondary	Change from Baseline of the Pain Catastrophizing Scale at week 6	Catastrophic thinking related to pain	Baseline; week 6	No