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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Efficacy of S-Adenosylmethionine in Fibromyalgia
Scientific title
Double-Blind, Placebo-Controlled Trial of the Impact of S-Adenosyl-L-Methionine (SAM-e) on the Mood and Other Symptoms in Fibromyalgia
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia Syndrome 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Study type
Description of intervention(s) / exposure
Other interventions - SAM-e (S-Adenosyl-L-Methionine)

Placebo Comparator: P - Placebo Control Group

Other interventions: SAM-e (S-Adenosyl-L-Methionine)
One 400 mg tablet daily in the morning.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
Timepoint [1] 0 0
Measured at three points in time: pre-trial and at 4 and 8 weeks
Secondary outcome [1] 0 0
Examination of dose-response data and the nature of the placebo effect in these conditions.
Timepoint [1] 0 0
Measured at three points in time: pre-trial and at 4 and 8 weeks

Key inclusion criteria
- Diagnosis of Fibromyalgia by a medical practitioner
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Pregnancy, Manic and hypomanic conditions

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Deakin University - Burwood
Recruitment postcode(s) [1] 0 0
3125 - Burwood

Funding & Sponsors
Primary sponsor type
Deakin University

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Gregory A Tooley, PhD
Address 0 0
Deakin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications