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Immune-Pineal Axis Function in Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02041455
First received: January 16, 2014
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Fibromyalgia
Drug: Melatonin and Placebo
Drug: Amitriptyline and Placebo
Drug: Melatonin and Amitriptylin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Pain Pressure Threshold (PPT) at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Pain Pressure Threshold by Fischer algometer on the tender points.

  • Change from Baseline Brain-derived neurotrophic factor at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
  • Change from Baseline of the Pain Catastrophizing Scale at week 6 [ Time Frame: Baseline; week 6 ] [ Designated as safety issue: No ]
    Catastrophic thinking related to pain


Estimated Enrollment: 66
Study Start Date: June 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041455

Contacts
Contact: Wolnei Caumo, PhD 555133598083 caumo@cpovo.net

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 900035-903
Contact: Simone de Azevedo Zanette, MD    555133598430      
Principal Investigator: Wolnei Caumo, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Wolnei d Caumo, PhD Hospital de Clinicas de Porto Alegre
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02041455     History of Changes
Other Study ID Numbers: 09-261
Study First Received: January 16, 2014
Last Updated: January 17, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital de Clinicas de Porto Alegre:
Fibromyalgia
Melatonin
Amitriptylin
Imune-pineal axis

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Melatonin
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antioxidants
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014