Clinical trial NCT01071044: Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome
Official title: Use of Lisdexamfetamine Dimesylate in Treatment of Cognitive Impairment (Chronic Fatigue Syndrome): A Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Fatigue Syndrome
Cognitive Impairments
Keywords: Chronic Fatigue Syndrome
Lead sponsor: Rochester Center for Behavioral Medicine
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2010-02-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: BRIEF-A
timeFrame: Every 2 weeks
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Every 2 weeks
measure: Hamiliton Anxiety Inventory
timeFrame: Every 2 weeks
measure: Short Form McGill Pain Questionnaire
timeFrame: Every 2 weeks
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Every 2 weeks
measure: Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)
timeFrame: Every 2 weeks
measure: Clinical Global Impression (Severity)
timeFrame: Every visit
Other outcomes:
Locations:
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
Study officials:
affiliation: Rochester Center for Behavioral Medicine
name: Joel L. Young, M.D.
role: PRINCIPAL_INVESTIGATOR
References: