The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Ventricular Lactate Levels in the Brain
研究概览
简要总结
Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.
详细描述
Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.
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 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
- •18 through 68 years of age
排除标准
- •Pregnant or trying to become pregnant
- •Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
- •Patients who do not indicate their pain levels as less than substantial despite their best care
- •History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
- •Presence of current depression as determined by psychiatric diagnostic interview
- •Presence of brain lesion on MRI anatomical study
研究组 & 干预措施
Patients taking the drug Milnacipran
Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.
干预措施: Milnacipran (Drug)
Patients taking the placebo
Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Ventricular Lactate Levels in the Brain
时间窗: Baseline and 2 months
Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.
次要结局
- Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).(Baseline and 2 months)
- Change in Widespread Pain(2 months)