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OpenTrials
Completed

NCT Number: NCT00528710

Efficacy of S-Adenosylmethionine in Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Deakin University

Burwood, Victoria, 3125, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Fibromyalgia by a medical practitioner

Exclusion criteria

  • Pregnancy, Manic and hypomanic conditions

Treatment and study plan

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

Dietary Supplement

One 400 mg tablet daily in the morning.

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Deakin University

Other

Registry information

Official study title

Double-Blind, Placebo-Controlled Trial of the Impact of S-Adenosyl-L-Methionine (SAM-e) on the Mood and Other Symptoms in Fibromyalgia

Important dates

Study start
2006
Study completion
2007
First posted
Sep 12, 2007
Registry last updated
Sep 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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