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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rochester Center for Behavioral Medicine
• Collaborator: Shire
• Treatments: Lisdexamfetamine Dimesylate

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