Trial Outcomes & Findings for Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome (NCT NCT01071044)
NCT ID: NCT01071044
Last Updated: 2025-09-09
Results Overview
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.
COMPLETED
PHASE4
26 participants
Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward
2025-09-09
Participant Flow
Study site began recruiting for the trial in Oct 2009 and the last subject completed the final visit on 3/7/11. Recruitment was done from within the Rochester Center (a private mental health practice), as well as some local advertising and community outreach.
Participant milestones
| Measure |
Lisdexamfetamine Dimesylate
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.
Lisdexamfetamine Dimesylate : 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).
|
Sugar Pill
Placebo Comparator: Sugar pill : 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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate
n=15 Participants
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.
Lisdexamfetamine Dimesylate : 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).
|
Sugar Pill
n=11 Participants
Placebo Comparator: Sugar pill : 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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in the analysis.
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.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in BRIEF-A
|
21.38 Scores on a scale
Standard Deviation 15.85
|
3.36 Scores on a scale
Standard Deviation 7.26
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in the analysis.
The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in Fatigue Severity Scale (FSS)
|
20.92 Scores on a scale
Standard Deviation 14.71
|
5.00 Scores on a scale
Standard Deviation 11.73
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in the analysis.
The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in Hamiliton Anxiety Inventory
|
11.31 Scores on a scale
Standard Deviation 9.74
|
6.18 Scores on a scale
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in analysis.
The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in Short Form McGill Pain Questionnaire
|
10.38 Scores on a scale
Standard Deviation 8.84
|
2.45 Scores on a scale
Standard Deviation 9.53
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in the analysis.
The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact. Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in Fibromyalgia Impact Questionnaire (FIQ)
|
20.90 Scores on a scale
Standard Deviation 25.54
|
8.83 Scores on a scale
Standard Deviation 18.14
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in the analysis.
The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)
|
18.17 Scores on a scale
Standard Deviation 11.95
|
8.73 Scores on a scale
Standard Deviation 7.80
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forwardPopulation: All participants were included in the analysis.
The Clinical Global Impression (Severity) is a one-item, 7-point clinician-rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). The clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.
Outcome measures
| Measure |
Treatment Group
n=15 Participants
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
|
Control Group
n=11 Participants
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Change in Clinical Global Impression (Severity)
|
1.92 Scores on a scale
Standard Deviation 1.50
|
.64 Scores on a scale
Standard Deviation .92
|
Adverse Events
Treatment Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=15 participants at risk
Lisdexamfetamine Dimesylate 30, 50, or 70 mg
|
Control Group
n=11 participants at risk
Placebo "30, 50 or 70 mg"
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/15 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
9.1%
1/11 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/15 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
9.1%
1/11 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Gastrointestinal disorders
Decreased Appetite
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Mouth
|
13.3%
2/15 • Number of events 2 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Nervous system disorders
Facial Tics
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Nervous system disorders
Headaches
|
26.7%
4/15 • Number of events 4 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
18.2%
2/11 • Number of events 2 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
9.1%
1/11 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Ear and labyrinth disorders
Sinus Infection
|
0.00%
0/15 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
36.4%
4/11 • Number of events 4 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
|
Metabolism and nutrition disorders
Weight Loss
|
6.7%
1/15 • Number of events 1 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
0.00%
0/11 • Each subject had a period of 10 weeks at which they could report any adverse events.
|
Additional Information
Joel L. Young, MD
Rochester Center for Behavioral Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place