Efficacy of S-Adenosylmethionine in Fibromyalgia

NCT00528710 | Completed Phase 2

• 1 other identifier: DUHREC06
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia Syndrome

Keywords

S-Adenosylmethionine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

P

PLACEBO COMPARATOR

Placebo Control Group

Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine)

Interventions

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

One 400 mg tablet daily in the morning.

P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Fibromyalgia by a medical practitioner

You may not qualify if:

• Pregnancy, Manic and hypomanic conditions

Sponsors & Collaborators

• Deakin University: lead

Study Sites (1)

Deakin University

Burwood, Victoria, 3125, Australia

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Gregory A Tooley, PhD

  Deakin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: September 12, 2007

Record last verified: 2007-09

Locations

AU (1)