Efficacy of S-Adenosylmethionine in Fibromyalgia

Fibromyalgia Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528710
• Other study ID #: DUHREC06
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2007
• Last updated: September 11, 2007
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: September 2007
• Source: Deakin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Fibromyalgia by a medical practitioner

Exclusion Criteria:

• Pregnancy, Manic and hypomanic conditions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• SAM-e (S-Adenosyl-L-Methionine)
One 400 mg tablet daily in the morning.

Locations

Country	Name	City	State
Australia	Deakin University	Burwood	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Deakin University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.		Measured at three points in time: pre-trial and at 4 and 8 weeks
Secondary	Examination of dose-response data and the nature of the placebo effect in these conditions.		Measured at three points in time: pre-trial and at 4 and 8 weeks