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

NCT01071044 | Completed Phase 4 Results

• 1 other identifier: RCBM11
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Fatigue Syndrome; Cognitive Impairments

Keywords

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in BRIEF-A

  The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.

  Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward

Secondary Outcomes (6)

• Change in Fatigue Severity Scale (FSS)

  Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward

• Change in Hamiliton Anxiety Inventory

  Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward

• Change in Short Form McGill Pain Questionnaire

  Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward

• Change in Fibromyalgia Impact Questionnaire (FIQ)

  Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward

• Change in Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)

  Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward

Study Arms (2)

Lisdexamfetamine Dimesylate

ACTIVE COMPARATOR

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.

Drug: Lisdexamfetamine Dimesylate

Sugar pill

PLACEBO COMPARATOR

Matching Placebo "30, 50 or 70 mg"

Drug: Placebo "30, 50 or 70 mg"

Interventions

Lisdexamfetamine Dimesylate DRUG

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.

Also known as: Vyvanse

Lisdexamfetamine Dimesylate

Placebo "30, 50 or 70 mg" DRUG

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.

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rochester Center for Behavioral Medicine: lead
• Shire: collaborator

Study Sites (1)

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Cognitive Dysfunction

Interventions

Lisdexamfetamine Dimesylate; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Carbohydrates

Limitations and Caveats

Relatively small sample size, imbalance of participants in active vs. placebo group due to pre-randomization, heterogenous sample (only one male participant in the study, who was in the control group and not the treatment group).

Results Point of Contact

• Title: Joel L. Young, MD
• Organization: Rochester Center for Behavioral Medicine

jyoung@rcbm.net

248-608-8800

Study Officials

• Joel L. Young, M.D.

  Rochester Center for Behavioral Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 9, 2025
• Results First Posted: June 26, 2014

Record last verified: 2025-08

Locations

US (1)