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
Study type: Interventional
Phase: Phase 4

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).
    

Detailed 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.
    

Intervention name(s): Lisdexamfetamine Dimesylate; Placebo "30, 50 or 70 mg"
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Vyvanse; Sugar pill
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Fatigue Syndrome