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Immune-Pineal Axis Function in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02041455
Recruitment Status : Unknown
Verified January 2014 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2010
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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

Primary Outcome Measures :
  1. Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 [ Time Frame: Baseline, week 6 ]
  2. Change from Baseline in Pain Pressure Threshold (PPT) at week 6 [ Time Frame: Baseline, week 6 ]
    Pain Pressure Threshold by Fischer algometer on the tender points.

  3. Change from Baseline Brain-derived neurotrophic factor at week 6 [ Time Frame: Baseline, week 6 ]

Secondary Outcome Measures :
  1. Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6 [ Time Frame: Baseline, week 6 ]
  2. Change from Baseline of the Pain Catastrophizing Scale at week 6 [ Time Frame: Baseline; week 6 ]
    Catastrophic thinking related to pain

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02041455

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Contact: Wolnei Caumo, PhD 555133598083

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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
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Study Director: Wolnei d Caumo, PhD Hospital de Clinicas de Porto Alegre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre Identifier: NCT02041455    
Other Study ID Numbers: 09-261
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Hospital de Clinicas de Porto Alegre:
Imune-pineal axis
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Amitriptyline, perphenazine drug combination
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents