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Efficacy of S-Adenosylmethionine in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00528710
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : September 12, 2007
Sponsor:
Information provided by:
Deakin University

Brief 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


Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Placebo Comparator: P
Placebo Control Group
Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine)
One 400 mg tablet daily in the morning.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Fibromyalgia by a medical practitioner

Exclusion Criteria:

  • Pregnancy, Manic and hypomanic conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528710


Locations
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Australia, Victoria
Deakin University
Burwood, Victoria, Australia, 3125
Sponsors and Collaborators
Deakin University
Investigators
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Principal Investigator: Gregory A Tooley, PhD Deakin University

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ClinicalTrials.gov Identifier: NCT00528710     History of Changes
Other Study ID Numbers: DUHREC06
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: September 12, 2007
Last Verified: September 2007

Keywords provided by Deakin University:
S-Adenosylmethionine

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases