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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
134
* Week 1 (take the following together twice a day-at breakfast and lunch) * One tablet of Methyl-P (5mg) * Four tablets of CFS Nutrient Formula * Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch): * Two tablets of Methyl-P (10mg) * Four tablets of CFS Nutrient Formula
* Week 1 (take the following together twice a day-at breakfast and lunch) * One tablet of Methyl-P Placebo * Four tablets of CFS Nutrient Placebo * Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch): * Two tablets of Methyl-P Placebo * Four tablets of CFS Nutrient Placebo
Stanford Chronic Fatigue Syndrome/ME Initiative
Stanford, California, United States
Nova Southeastern University
Fort Lauderdale, Florida, United States
Susan Levine, MD
New York, New York, United States
Fatigue Consultation Clinic
Salt Lake City, Utah, United States
Change in patient reported Checklist Individual Strength (CIS) Total Score
Time frame: Week 12
Percentage of patients with 20% or greater improvement in the CIS total score
Time frame: Week 12
Concentration Disturbances Subscore on the CIS
Time frame: Week 12
Concentration Disturbances Score by Visual Analog Scale (VAS)
Time frame: Week 12
Fatigue Score by Visual Analog Scale (VAS)
Time frame: Week 12
Pain Symptoms by Brief Pain Inventory Form
Time frame: Week 12
Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)
Time frame: Week 12
Number of Participants with Adverse Events to Assess Safety and Tolerability
Time frame: Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.