Methylphenidate

Methylphenidate is a central nervous system (CNS) stimulant, most often used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. Methylphenidate hydrochloride has many brand names, including Tranquilyn and Ritalin.

Theory

Methylphenidate increases activity in areas of the brain that are underactive in ADHD, including those involved in impulsive behavior and concentration.

KPAX002 mitochondria nutrients

Dr. Jon Kaiser is performing clinical trials on a pharmaceutical product which he developed called Synergy (KPAX002) which is a combination of a low dosage of methylphenidate hydrochloride and over-the-counter mitochondrial support nutrients.

The KPAX002 mitochondria support nutrients are:

• Acetyl-L-carnitine (ALCAR), which has a role in metabolism
• alpha lipoic acid (ALA, an antioxidant)
• beta carotene, an antioxidant
• N-acetyl-cysteine

plus vitamins:

• vitamin B1, vitamin B2, niacinamide (a form of vitamin B3), vitamin B5 (pantothenic acid), vitamin B7 (biotin), vitamin C

plus the minerals:

• boron, copper, iodine, inositol, iron, magnesium, manganese, potassium, selenium, zinc

Evidence

The Canadian Consensus Criteria suggests using methylphenidate in the mornings only for fatigue, increased energy and alertness, and cautions that it may be habit forming.

Methylphenidate has been used with success in a subset of ME/CFS patients. In 2016, Blockmans, et al, concluded that use of methylphenidate by CFS patients with concentration difficulties had a positive effect in about one out of three clinical trial patients.

The phase II study concluded that 36% of the patients taking the Synergy treatment had a >20% reduction in overall ME/CFS symptoms after 28 days. Kaiser patented the KPAX002 combination prior to publishing the trial results.

Dosage

A low dose is suggested for ME/CFS of 5 - 10mg in the mornings.

Notable studies

• 2015, A prospective, proof-of-concept investigation of KPAX002 in chronic fatigue syndrome. (Full Text)

• 2016, Long-term methylphenidate intake in chronic fatigue syndrome (Abstract)

• 2018, KPAX002 as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A prospective, randomized trial (Full Text)

Risks and safety

A wide variety of side effects have been reported, some of which need immediate medical attention.

Common side effects include suicidality, mood swings and heart problems.

Costs and availability

Prescription only

See also

• Jon Kaiser
• KPAX002

Learn more

• Tranquilin patient information leaflet - drugs.com
• Methylphenidate FDA prescribing information - drugs.com

central nervous system (CNS) - One of the two parts of the human nervous system, the other part being the peripheral nervous system. The central nervous system consists of the brain and spinal cord, while the peripheral nervous system consists of nerves that travel from the central nervous system into the various organs and tissues of the body.

mitochondria Important parts of the biological cell, with each mitochondrion encased within a mitochondrial membrane. Mitochondria are best known for their role in energy production, earning them the nickname "the powerhouse of the cell". Mitochondria also participate in the detection of threats and the response to these threats. One of the responses to threats orchestrated by mitochondria is apoptosis, a cell suicide program used by cells when the threat can not be eliminated.

phase two A trial involve patients to assess side effects and effectiveness for a particular clinical condition. Typically 100-300 patients.

See myalgic encephalomyelitis.

See chronic fatigue syndrome.

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.