Efficacy of S-Adenosylmethionine in Fibromyalgia - Full Text View

Sponsored by:	Deakin University
Information provided by:	Deakin University
ClinicalTrials.gov Identifier:	NCT00528710

Purpose

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

Condition	Intervention	Phase
Fibromyalgia Syndrome	Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine)	Phase II

MedlinePlus related topics: Fibromyalgia

Drug Information available for: S-Adenosylmethionine Methionine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Deakin University:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Enrollment:	70
Study Start Date:	November 2006
Study Completion Date:	March 2007

Arms	Assigned Interventions
P: Placebo Comparator Placebo Control Group	Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine) One 400 mg tablet daily in the morning.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Fibromyalgia by a medical practitioner

Exclusion Criteria:

Pregnancy, Manic and hypomanic conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528710

Locations

Australia, Victoria
Deakin University
Burwood, Victoria, Australia, 3125

Sponsors and Collaborators

Deakin University

Investigators

Principal Investigator:

Gregory A Tooley, PhD

Deakin University

More Information

Study ID Numbers:	DUHREC06
Study First Received:	September 11, 2007
Last Updated:	September 11, 2007
ClinicalTrials.gov Identifier:	NCT00528710
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Deakin University:

S-Adenosylmethionine

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009