Efficacy of S-Adenosylmethionine in Fibromyalgia

Deakin University70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibromyalgia Syndrome

Interventions

One 400 mg tablet daily in the morning.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Fibromyalgia by a medical practitioner Exclusion Criteria: * Pregnancy, Manic and hypomanic conditions

Locations (1)

Deakin University

Burwood, Victoria, Australia

Outcomes

Primary Outcomes

Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.

Time frame: Measured at three points in time: pre-trial and at 4 and 8 weeks

Secondary Outcomes

Examination of dose-response data and the nature of the placebo effect in these conditions.

Time frame: Measured at three points in time: pre-trial and at 4 and 8 weeks

Data from ClinicalTrials.gov

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