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Immune-Pineal Axis Function in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Melatonin and Placebo
Amitriptyline and Placebo
Melatonin and Amitriptylin
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Melatonin, Amitriptylin, Imune-pineal axis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Melatonin and Placebo

Amitriptyline and placebo

Melatonin and Amitriptylin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2014
Last Updated
January 17, 2014
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02041455
Brief Title
Immune-Pineal Axis Function in Fibromyalgia
Official Title
Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Melatonin, Amitriptylin, Imune-pineal axis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin and Placebo
Arm Type
Experimental
Arm Description
Melatonin 10mg and placebo, once in the evening, for 6 weeks.
Arm Title
Amitriptyline and placebo
Arm Type
Experimental
Arm Description
Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.
Arm Title
Melatonin and Amitriptylin
Arm Type
Active Comparator
Arm Description
Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Melatonin and Placebo
Intervention Type
Drug
Intervention Name(s)
Amitriptyline and Placebo
Intervention Type
Drug
Intervention Name(s)
Melatonin and Amitriptylin
Primary Outcome Measure Information:
Title
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Time Frame
Baseline, week 6
Title
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
Description
Pain Pressure Threshold by Fischer algometer on the tender points.
Time Frame
Baseline, week 6
Title
Change from Baseline Brain-derived neurotrophic factor at week 6
Time Frame
Baseline, week 6
Secondary Outcome Measure Information:
Title
Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6
Time Frame
Baseline, week 6
Title
Change from Baseline of the Pain Catastrophizing Scale at week 6
Description
Catastrophic thinking related to pain
Time Frame
Baseline; week 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolnei Caumo, PhD
Phone
555133598083
Email
caumo@cpovo.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei d Caumo, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
900035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone de Azevedo Zanette, MD
Phone
555133598430
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25052847
Citation
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.
Results Reference
derived

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Immune-Pineal Axis Function in Fibromyalgia

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