Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome; Cognitive Impairments
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue; Cognitive Dysfunction
Intervention: Lisdexamfetamine Dimesylate; Placebo "30, 50 or 70 mg"
Intervention description: Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. 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.; Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. 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.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic Fatigue Syndrome

Summary:

      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).
    

Eligibility criteria:

        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