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Efficacy of S-Adenosylmethionine in Fibromyalgia

Primary Purpose

Fibromyalgia Syndrome

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring S-Adenosylmethionine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Fibromyalgia by a medical practitioner

Exclusion Criteria:

Pregnancy, Manic and hypomanic conditions

Sites / Locations

Deakin University

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

Arm Description

Placebo Control Group

Outcomes

Primary Outcome Measures

Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.

Secondary Outcome Measures

Examination of dose-response data and the nature of the placebo effect in these conditions.

Full Information

NCT ID

NCT00528710

First Posted

September 11, 2007

Last Updated

September 11, 2007

Sponsor

Deakin University

1. Study Identification

Unique Protocol Identification Number

NCT00528710

Brief Title

Efficacy of S-Adenosylmethionine in Fibromyalgia

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 Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Deakin University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia Syndrome

Keywords

S-Adenosylmethionine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo Control Group

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

One 400 mg tablet daily in the morning.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Fibromyalgia by a medical practitioner Exclusion Criteria: Pregnancy, Manic and hypomanic conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory A Tooley, PhD

Organizational Affiliation

Deakin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deakin University

City

Burwood

State/Province

Victoria

ZIP/Postal Code

3125

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

Efficacy of S-Adenosylmethionine in Fibromyalgia

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