Immune-Pineal Axis Function in Fibromyalgia

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02041455

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Drug: Melatonin and Placebo Drug: Amitriptyline and Placebo Drug: Melatonin and Amitriptylin	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin and Placebo Melatonin 10mg and placebo, once in the evening, for 6 weeks.	Drug: Melatonin and Placebo
Experimental: Amitriptyline and placebo Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.	Drug: Amitriptyline and Placebo
Active Comparator: Melatonin and Amitriptylin Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.	Drug: Melatonin and Amitriptylin

Arm

Intervention/Treatment

Experimental: Melatonin and Placebo

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

Drug: Melatonin and Placebo

Experimental: Amitriptyline and placebo

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

Drug: Amitriptyline and Placebo

Active Comparator: Melatonin and Amitriptylin

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

Drug: Melatonin and Amitriptylin

Outcome Measures

Primary Outcome Measures

Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 [Baseline, week 6]
Change from Baseline in Pain Pressure Threshold (PPT) at week 6 [Baseline, week 6]
Pain Pressure Threshold by Fischer algometer on the tender points.
Change from Baseline Brain-derived neurotrophic factor at week 6 [Baseline, week 6]

Secondary Outcome Measures

Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6 [Baseline, week 6]
Change from Baseline of the Pain Catastrophizing Scale at week 6 [Baseline; week 6]
Catastrophic thinking related to pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women 18-65 years old
Fibromyalgia according to the criteria of the American College of Rheumatology (Wolfe

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