A Clinical Trial Investigating a Combination of a
CFS Nutrient Formula plus a Currently Available
Medication to Treat Chronic Fatigue Syndrome

A Brief Description of this Study

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 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 low dose 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 (10-20mg per day). 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.

The Synergy Trial will enroll 120 participants at four (4) research sites throughout the United States. The duration of the study intervention is 12-weeks. Sites currently include:

Palo Alto, CA (Stanford University)
• Manhattan, NY
• Salt Lake City, UT
• Fort Lauderdale, FL

Study Rationale

Three of the most debilitating symptoms of Chronic Fatigue Syndrome (CFS) are poor stamina, post-exertional fatigue, and brain fog (decreased alertness and concentration). While at present there is no known cause of CFS, several recent studies have suggested that the mitochondria (the part of the cell which generates energy) may be functioning poorly. The mitochondria utilize most of the antioxidants we consume. Several micronutrient supplements have been tried to address mitochondrial dysfunction in CFS but none have shown to be reliably beneficial.

The CFS Nutrient Formula we are studying in this trial is based on two decades of clinical experience and contains micronutrients and cofactors that are known to support and enhance the efficiency of mitochondrial functioning. These include acetyl-L-carnitine, alpha lipoic acid, N-acetyl cysteine, L-taurine, B-vitamins, and others.

The rationale for administering low dose methylphenidate (generic Ritalin®) to CFS patients who are concurrently taking this CFS-specific nutrient formula is as follows:

The CFS Nutrient Formula provides the cellular fuel (antioxidants, amino acids and mitochondrial cofactors), while the low-dose methylphenidate (generic Ritalin®) provides a potent catalyst (i.e. spark) to enhance the metabolism of this fuel and the production of cellular energy.

When this combination of treatments (low dose methylphenidate plus the CFS Nutrient Formula) was recently provided to CFS patients as innovative therapy, many patients reported rapid and sustained reductions in fatigue as well as improvement in concentration (brain fog) when measured by the Checklist Individual Strength questionnaire and other patient-reported outcome measurement tools. The Synergy Trial represents the next phase of study for this intervention.

The Synergy Trial seeks to confirm these preliminary findings, expand on the observations made in prior research studies, and further explore the safety and efficacy of using low-dose methylphenidate (generic Ritalin®) in CFS patients who are also taking a CFS Nutrient Formula during a 12-week period.