Use of Lisdexamfetamine Dimesylate in Treatment of Cognitive Impairment (Chronic Fatigue Syndrome): A Double Blind, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in BRIEF-A
研究概览
简要总结
Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these patients is a history of unexplained fatigue and musculoskeletal pain.
Treatment of these patients in our clinic has revealed that when their underlying ADHD is treated with psychostimulant medication, many patients report significant improvements with regard to their fatigue and musculoskeletal pain. Patients report less subjective fatigue and pain and note overall functional improvement, although the initial and primary objective was the treatment of their attention or hyperactivity problems. We speculate that stimulants are efficacious by offering two distinct clinical properties. 1) anti-fatigue properties and 2) properties that allow patients to filter out extraneous stimuli (i.e. chronic muscle pain).
详细描述
As a result of these findings RCBM developed a chronic fatigue/fibromyalgia clinic in the early 2000's. This clinic was staffed by a board-certified rheumatologist and the psychiatric staff at RCBM. Through the major referral hospital in the area, patients with self-identified fibromyalgia and chronic fatigue were referred to our clinic. Over eighteen months, we evaluated 75 patients, and found that in patients who had comprehensive evaluations, nearly 70 percent also had a history of ADHD, inattentive or combined types. Diagnosis was made using clinical history and standardized symptom checklists. Oftentimes, the ADHD had been previously undiagnosed. This finding supports the link between ADHD and FMS/CFS.
Results from these evaluations reinforced our initial findings: patients who are treated for their ADHD symptoms also show a reduction in their chronic pain and fatigue symptoms. This is true regardless of previous (unsuccessful) therapies to treat their fibromyalgia.
As a result of these findings, we are conducting a controlled study to further demonstrate the efficacy of lisdexamfetamine dimesylate (LDX) in controlling fatigue symptoms in patients presenting with chronic fatigue syndrome. This is a double-blind, placebo-controlled study over a period of 8 weeks, where subjects are randomized to either LDX or placebo. We will evaluate subjects through standardized pain, fatigue and ADHD assessment scales.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BRIEF-A Global Executive Composite score (GEC) ≥ 65, or Behavioral Regulation Index score (BRI) ≥ 65, or Metacognition Index score (MI) ≥
- •Subjects must meet consensus criteria for chronic fatigue syndrome.
- •Provide written informed consent for participation in the trial before completing any study-related procedures.
- •18-60 years at time of consent
- •Male or non-pregnant females who are not breastfeeding.
- •Females of reproductive potential must agree to use a medically accepted means of contraception when engaging in sexual intercourse at any time during the study.
- •Are able to swallow study medication.
排除标准
- •CFS and executive functioning impairment are not present or not diagnosable
- •Serious comorbid psychiatric condition
- •Subjects who were pregnant, nursing, or intended to become pregnant
- •Subjects who had been on a psychostimulant regimen in the last six months
- •Subjects who had a medical condition that would have been affected by psychostimulant medication
- •Subjects who were of low intelligence, or who were unable to communicate effectively with the study team
研究组 & 干预措施
Lisdexamfetamine Dimesylate
Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
干预措施: Lisdexamfetamine Dimesylate (Drug)
Sugar pill
Matching Placebo "30, 50 or 70 mg"
干预措施: Placebo "30, 50 or 70 mg" (Drug)
结局指标
主要结局
Change in BRIEF-A
时间窗: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward
The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.
次要结局
- Change in Fatigue Severity Scale (FSS)(Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward)
- Change in Hamiliton Anxiety Inventory(Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward)
- Change in Short Form McGill Pain Questionnaire(Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward)
- Change in Clinical Global Impression (Severity)(Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward)
- Change in Fibromyalgia Impact Questionnaire (FIQ)(Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward)
- Change in Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)(Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward)
研究者
Joel L. Young, M.D.
Principal Investigator
Rochester Center for Behavioral Medicine