Immune-Pineal Axis Function in Fibromyalgia

NCT02041455 | Unknown Phase 2 DMC

• 1 other identifier: 09-261
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Melatonin; Amitriptylin; Imune-pineal axis

Outcome Measures

Primary Outcomes (3)

• 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

  Pain Pressure Threshold by Fischer algometer on the tender points.

  Baseline, week 6

• Change from Baseline Brain-derived neurotrophic factor at week 6

  Baseline, week 6

Secondary Outcomes (2)

• 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

Study Arms (3)

Melatonin and Placebo

EXPERIMENTAL

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

Drug: Melatonin and Placebo

Amitriptyline and placebo

EXPERIMENTAL

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

Drug: Amitriptyline and Placebo

Melatonin and Amitriptylin

ACTIVE COMPARATOR

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

Drug: Melatonin and Amitriptylin

Interventions

Melatonin and Placebo DRUG

Melatonin and Placebo

Amitriptyline and Placebo DRUG

Amitriptyline and placebo

Melatonin and Amitriptylin DRUG

Melatonin and Amitriptylin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 900035-903, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 25052847 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Melatonin; Amitriptyline

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Wolnei d Caumo, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Wolnei Caumo, PhD

CONTACT

555133598083; caumo@cpovo.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 22, 2014
• Study Start: June 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

BR (1)