Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome

Rochester Center for Behavioral Medicine

Status and phase: Completed; Phase 4

Conditions: Chronic Fatigue Syndrome; Cognitive Impairments

Treatments: Drug: Lisdexamfetamine Dimesylate; Drug: Placebo "30, 50 or 70 mg"

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01071044

RCBM11

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BRIEF-A Global Executive Composite score (GEC) ≥ 65, or Behavioral Regulation Index score (BRI) ≥ 65, or Metacognition Index score (MI) ≥ 65.
• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Lisdexamfetamine Dimesylate

Active Comparator group

Description:

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.

Treatment:

Drug: Lisdexamfetamine Dimesylate

Sugar pill

Placebo Comparator group

Description:

Matching Placebo "30, 50 or 70 mg"

Treatment:

Drug: Placebo "30, 50 or 70 mg"