SUNSET, La., July 29, 2015 (GLOBE NEWSWIRE) -- Major Depressive Disorder (MDD) affects up to 25% of people and the literature is clear that previous standards of treatment fall short: only 30% of patients will achieve remission and up to 70% of those taking standard antidepressants will discontinue use due to side effects. While it is known that homocysteine, a toxic amino acid synthesized from methionine, is implicated in inflammation, a recent study investigating the direct correlation between homocysteine levels and depression had not been conducted.
There are many environmental and genetic factors that contribute to depression and response to treatment. One of the most common genetic risk factors is the MTHFR enzyme polymorphism. MTHFR (Methylenetetrahydrofolate Reductase) is the enzyme encoded and responsible for folate/folic acid metabolism. Up to 90% of people struggling with depression have a defect of the MTHFR enzyme resulting in reduced activity of the enzyme and consequently impaired metabolism of the B vitamins critical to the production of serotonin, norepinephrine, and dopamine.
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 sponsored by JayMac Pharmaceuticals, makers of EnLyte, and conducted by Arnie Mech, MD and Andrew Farah, MD. 330 patients with confirmed polymorphisms of the MTHFR enzyme and a DSM-V diagnosis of MDD were randomized to receive either EnLyte as monotherapy or placebo for 8 weeks. Homocysteine levels were drawn at baseline and 8 weeks; Montgomery-Asperg scales were administered to measure depression response to each agent. The average age was 32.
The EnLyte group separated from placebo in both homocysteine levels and depression scores by week 2. By week 8, homocysteine levels had decreased by 32% compared to placebo. The placebo group continued to experience a slight rise in homocysteine. 42% of the EnLyte group achieved remission of depression by week 8. Patients reported a side effect profile similar to placebo.
"These results confirm the homocysteine theory of depression and the therapeutic benefit and safety of using reduced B vitamins (EnLyte) as monotherapy in depressive disorders in the presence of proven or suspected MTHFR polymorphisms." Andrew Farah, MD
EnLyte is an advanced generation folate therapy by prescription FDA regulated to treat conditions related to hyperhomocysteinemia and/or suboptimal folate levels including as monotherapy or adjunctive therapy to an SSRI/SNRI in depression. EnLyte contains L-methylfolate magnesium, folinic acid, folacin, brain-ready cofactors of b1, b2, b3, b6, b12, betaine, zinc, magnesium, vitamin c, and PS gold omega 3s. EnLyte is pregnancy category A and safe for use in children. EnLyte is paid by many insurance plans at a reasonable copay and available through cash pay mail order for $58 per month. For more information or licensed prescriber samples, contact EnLyte Customer Care, 985.788.7755 or visit www.EnLyteRx.Com
CONTACT: Angela Hall JayMac Pharmaceuticals 850-602-1617Source:JayMac Pharmaceuticals(EnLyte)