The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome

This is an interventional treatment trial for Chronic Fatigue Syndrome (CFS) focused on measuring Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME), central nervous system (CNS), fatigue, alertness, brain fog, mitochondria, methylphenidate, Ritalin, stimulant, multivitamin, multimineral, micronutrients, supplements Read More

Inclusion Criteria:

• Subjects must fulfill the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959)
• Subjects must also report alertness and/or concentration deficits
• Otherwise in good health based on medical history and screening evaluation
• Willingness to NOT take any nutritional or herbal supplements other than the study treatment during the course of the trial

• Nutritional supplements that are exempted from this requirement are limited to the following:

  • Probiotic supplements
  • Fiber supplements
  • Fish oil supplements
  • Digestive enzymes
  • Melatonin ≤ 10mg per day
  • Calcium ≤ 600 mg per day
  • Magnesium ≤ 400 mg per day
  • Vitamin D ≤ 400 i.u. per day

• Willingness to NOT consume any caffeine-containing supplements during the study period (coffee, tea, or chocolate are exempt). These include but are not limited to the following beverages:

  • Red Bull®
  • Monster®
  • Rockstar®
  • 5-hour® energy shots
• Willingness to NOT consume any pseudoephedrine-containing products during the study period
• Willingness to practice effective contraception

Exclusion Criteria:

• Pregnancy or lactation
• Active substance abuse
• Major depression as defined by Zung Depression Scale score ≥ 60
• Use of rintatolimod (Ampligen®) within the past 3 months
• Currently taking any prescription medication to treat anxiety on a daily basis

• Use of more than 3 times/week within the past 3 months of:

  • Monoamine oxidase inhibitors (MAOs)
  • Anti-psychotic medications
  • CNS stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, amphetamines)
  • Narcotic opioids
  • Tramadol (i.e. Ultram®, Ultracet®, Conzip®, or Ryzolt®)
  • Gabapentin (Neurontin®) > 600mg/day
  • Pregabalin (Lyrica®)
  • Duloxetine (Cymbalta®)
  • Milnacipran (Savella®)
  • Coumarin anticoagulants (Coumadin®)
  • Valganciclovir (Valcyte®)

• Daily concurrent use of more than one antidepressant medication except if one of the two antidepressant medications are:

  • Amitriptyline ≤ 30mg at bedtime
  • Trazodone ≤ 50mg at bedtime
  • Doxepin ≤ 20mg at bedtime

• Active medical conditions to which treatment with methylphenidate hydrochloride or micronutrients may be contraindicated, including:

  • Glaucoma
  • Diabetes Mellitus
  • Current stomach or duodenal ulcer
  • Uncontrolled hypertension (blood pressure at screening of systolic >150 or diastolic >90)
  • Heart disease (including cardiac arrhythmia, cardiac ischemia, syndrome of Gilles de la Tourette or a past history of myocardial infarction or cerebrovascular event)
  • Motor tics or family history of psychosis or bipolar disorder
  • Previous history or seizures

• A diagnosis of other conditions that may be in part responsible for the patient's fatigue including, but not limited to:

  • HIV infection
  • Chronic Hepatitis B & C
  • Cancer (receiving treatment either currently or within the past two years)
  • Chronic Renal Disease
• Clinically significant laboratory test values as determined by the Investigator
• Clinically significant ECG abnormalities as determined by the Medical Monitor
• Compliance criteria: A subject will not be eligible if he/she, in the opinion of the Investigator, will be unable to comply with any aspect of this study protocol, including the visit schedule.