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Efficacy of S-Adenosylmethionine in Fibromyalgia

NCT ID: NCT00528710

Last Updated: 2007-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-03-31

Brief Summary

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Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e in the treatment of depressed mood and general symptoms of fibromyalgia (FMS).

As such, salient clinical and pathological parameters will be assessed over an 8-week period in 60 patients who will be provided with either SAM-e or a placebo preparation . On the basis of previous literature, it is hypothesised that patients in the active treatment group will experience moderate but significant improvements across the clinical measures, and that these gains will be significantly greater than any reported in the placebo group. All patients will provide informed consent. All procedures will be conducted under medical supervision and the preparation itself is very safe when used in the manner proposed for the trial

Detailed Description

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Conditions

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Fibromyalgia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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P

Placebo Control Group

Group Type PLACEBO_COMPARATOR

SAM-e (S-Adenosyl-L-Methionine)

Intervention Type DIETARY_SUPPLEMENT

One 400 mg tablet daily in the morning.

Interventions

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SAM-e (S-Adenosyl-L-Methionine)

One 400 mg tablet daily in the morning.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Fibromyalgia by a medical practitioner

Exclusion Criteria

* Pregnancy, Manic and hypomanic conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deakin University

OTHER

Sponsor Role lead

Principal Investigators

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Gregory A Tooley, PhD

Role: PRINCIPAL_INVESTIGATOR

Deakin University

Locations

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Deakin University

Burwood, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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DUHREC06

Identifier Type: -

Identifier Source: org_study_id