SUNSET, La., July 29, 2015 (GLOBE NEWSWIRE) -- It has been common knowledge in the medical community that administering B9 (folates), B12, and B6 will lower homocysteine levels in the body. However, as much as this is common thought there have never been many clinical trials to demonstrate this quantitatively and the qualitative effects it can have in improving depression.
These ingredients in their metabolized or coenzyme forms are needed to operate the complex chemical factory called methylation in the cells to accomplish many biochemical tasks including in the brain normal production of neurotransmitters, Sam-E, and glutathione, an important antioxidant. In addition, homocysteine is created in the body and is a catalyst in this process. If these ingredients aren't available it can build up and cause neurological and cardiovascular inflammatory damage. There are many inborn and environmental con founders that can inhibit these ingredients that are needed to operate this chemical factory called methylation. One of the most common inborn con founders is a genetic defect called MTHFR Polymorphism that prevents normal production of the enzyme system needed to metabolize food folate and/or folic acid B9 into the coenzyme form needed to operate methylation, L-methylfolate. As much as 60% of the US population, and 90% of depressed individuals, have this defect which puts them at risk for clinical depression when they experience stress.
In an attempt to demonstrate the effect of a new advanced generation Rx folate gel cap, EnLyte, containing coenzymes and cofactors that target the needs of proper methylation on homocysteine levels and depression symptoms, JayMac Pharmaceuticals sponsored a clinical trial in the use of EnLyte in 330 MTHFR Polymorphic patients with Major Depressive Disorder. The study "Reduced B Vitamin Therapy in MTHFR C677T/A1298C Patients with Major Depressive Disorder-Clinical Response Correlates with Homocysteine Reduction: A Double- Blind, Placebo-Controlled Study" was conducted in Dallas, Texas by investigators Arnie Mech,MD and Andrew Farah, MD.
160 patients were randomized to receive placebo, while 170 received EnLyte Gel Cap. Treatment response was associated with a significant reduction in Homocysteine (HCY) levels, 32.9% compared to placebo. Patients receiving placebo experienced, on average, a slight, non-significant increase in HCY levels of 0.4 umol/L. The active EnLyte group when used in the treatment of Major Depressive Disorder in MTHFR positive patients, significantly separated from placebo by week two of treatment on the MADRS rating scale, and separation expanded throughout the trial. Montgomery-Asberg score was reduced by 12 points on average in the treatment group with 55 of 131 (42%) achieving remission by the week 8 visit. No side-effects were reported at a greater than placebo rate, no patients converted to mania, and no patients reported new-onset suicidal thinking on either EnLyte or placebo.
These results confirm the HCY theory of depression and the therapeutic benefit and safety of using EnLyte as monotherapy in depressive disorders particularly in the presence of MTHFR Polymorphisms.
For questions or licensed prescriber samples of EnLyte, contact EnLyte Customer Care, 985.788.7755 or visit www.EnLyteRx.Com.
CONTACT: Angela Hall JayMac Pharmaceuticals 850-602-1617Source:JayMac Pharmaceuticals