the synergy trial: methylphenidate plus a cfs-specific nutrient formula as a treatment for chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)

Summary: the synergy trial will evaluate the safety and efficacy of a currently available medication (methylphenidate hydrochloride) combined with a cfs-specific dietary supplement (cfs nutrient formula) to treat chronic fatigue syndrome (cfs).

the synergy trial will evaluate the safety and efficacy of a currently available medication (methylphenidate) combined with a cfs-specific dietary supplement (cfs nutrient formula) to treat chronic fatigue syndrome (cfs). the cfs nutrient formula to be used in this trial is a broad-spectrum micronutrient supplement that provides cfs patients with vitamins, minerals, and other cofactors (amino acids, antioxidants, and mitochondrial cofactors) to complement the low-dose central nervous system (cns) stimulant (methylphenidate). in other words, therapeutic dosages of micronutrients are provided to support the functioning of the nervous, endocrine, and immune systems to a level at which a lower than customary dosage of methylphenidate can produce positive clinical effects on cfs symptoms and also be well tolerated. methylphenidate is the generic form of ritalin®. the dose being tested in this study is relatively low (5-10mg twice daily). this drug has been in clinical use for over 50 years for the treatment of narcolepsy and attention deficit disorder and has a well-described safety profile when used as recommended. methylphenidate alone has been studied as a treatment for cfs in the past and has been shown to produce mild benefits and be well-tolerated. when provided as innovative therapy, methylphenidate plus this cfs nutrient formula has produced substantial improvements in cfs symptoms in a limited number of patients, and demonstrated excellent tolerability. use of low dose methylphenidate hydrochloride coadministered with a cfs nutrient formula has not been previously evaluated in a controlled clinical study. the risk to patients using this combination is believed to be low, especially in the context of a well-controlled clinical study. furthermore, this combination is not expected to increase the incidence or severity of adverse events associated with methylphenidate hydrochloride.

Eligibility criteria:
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.

Keywords: chronic fatigue syndrome (cfs) myalgic encephalomyelitis (me) central nervous system (cns) fatigue alertness brain fog mitochondria methylphenidate ritalin stimulant multivitamin multimineral micronutrients supplements