Double-Blind, Placebo-Controlled Trial of the Impact of S-Adenosyl-L-Methionine (SAM-e) on the Mood and Other Symptoms in Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Fibromyalgia by a medical practitioner
排除标准
- •Pregnancy, Manic and hypomanic conditions
结局指标
主要结局
Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
时间窗: Measured at three points in time: pre-trial and at 4 and 8 weeks
次要结局
- 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)