NCT00528710

Efficacy of S-Adenosylmethionine in Fibromyalgia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Deakin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SAM-e (S-Adenosyl-L-Methionine)	One 400 mg tablet daily in the morning.

Timeline

• Start date: 2006-11-01
• Completion: 2007-03-01
• First posted: 2007-09-12
• Last updated: 2007-09-12

Locations

1 site across 1 country: Australia