Chronic Fatigue Syndrome

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. These criteria will be assessed by obtaining clinical histories and using appropriate symptom checklists.
• Provide written informed consent for participation in the trial before completing any study-related procedures.
• Are between the ages of 18 and 60, inclusive, at the time informed consent is obtained.
• 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. Females with childbearing potential who are abstinent may enter the study if they agree that they will use medically acceptable contraception should they should become sexually active during the study. Women of childbearing potential must test negative for pregnancy at the Screening Visit.
• Are able to swallow study medication.
• Have normal intelligence, are able to communicate effectively with the study team and are likely to fully comply with study procedures and restrictions, including all clinic visits and assessments required by the protocol.

Exclusion Criteria:

• BRIEF-A Global Executive Composite score < 65, or Behavioral Regulation Index score (BRI) < 65, or Metacognition Index score (MI) < 65.
• Immediate family of the Investigator or others directly affiliated with the study.
• Received treatment with a drug that has not received regulatory approval or participated in a clinical trial within 30 days prior to screening.
• Weigh less than 30 kg or greater than 120 kg at the time of informed consent, or in the opinion of the Investigator, are significantly underweight or morbidly obese.
• Have a documented history of Bipolar I Disorder or any history of psychosis or pervasive developmental disorder. In addition, subjects with any comorbid psychiatric diagnosis with significant symptoms (severe Axis II disorder, or severe Axis I disorders such as post-traumatic stress disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorders) will be excluded. Subjects with mild to moderate Axis I disorders such as social phobia and dysthymia and ADHD may be included.
• History of substance abuse or drug dependence according to DSM-IV-TRTM criteria currently or within one year prior to study participation, excluding nicotine and caffeine. This is determined through clinical history and symptom checklist to be obtained at visit 1.
• Serious chronic or acute unstable medical condition or illness, including cardiovascular, hepatic, renal, respiratory, or hematologic illness, narrow angle glaucoma, or other unstable medical or psychiatric conditions that in the opinion of the Investigator would compromise participation or would likely lead to hospitalization during the duration of the study. Subjects with a history of mental retardation or a severe learning disability are also excluded.
• History of seizure disorder (other than infantile febrile seizures), any tic disorder, current diagnosis and/or family history of Tourette's disorder.
• Subjects with a history of organic heart disease including coronary artery disease, past myocardial infarction, angina, arrhythmias, congestive heart failure, valvular heart disease and congenital heart disease.
• Subject has a history of hypertension, unless controlled with a stable dose of blood pressure medication for a period of three months or more, or has a resting sitting systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg.
• Patients who are taking any excluded medications that cannot be discontinued prior to beginning treatment with study medication.
• Have a known hypersensitivity, allergy intolerance or documented history of non-responsivity to methylphenidate or amphetamine, to amphetamine-based medications, to LDX, or to any of its ingredients.
• Subjects who, in the opinion of the Investigator, are unsuitable in any other way to participate in the study.
• Subjects on duloxetine, bupropion or pregabalin.