SAN DIEGO--()--At the U.S. Psychiatric and Mental Health Congress, November 8-11 in San Diego, Dr. Rakesh Jain and Dr. George Papakostas will discuss various biomarkers and genotypes associated with major depression and those which may predict patient response to adjunctive L-methylfolate, the bioavailable form of folate. L-methylfolate is needed by the brain to synthesize neurotransmitters associated with mood.
“consistent signal suggesting that something is going on with respect to the metabolic, inflammatory, and oxidative profile of some patients that renders them particularly susceptible to the therapeutic effects of L-methylfolate as adjunctive therapy above and beyond placebo”
L-methylfolate is an effective and well-tolerated adjunctive therapy for patients with major depressive disorder -- particularly those with certain biomarkers and genotypes associated with metabolic dysfunction -- who fail to respond adequately to treatment using selective serotonin reuptake inhibitors (SSRI).
L-methylfolate, categorized as a trimonoamine modulator, was shown in a 2011 double-blind, placebo-controlled study of 75 patients with SSRI-resistant major depressive disorder (MDD) to be superior to placebo as an adjunctive therapy when given at a dose of 15 mg/day.
In the study, twice as many depressed patients achieved response (50% reduction in Hamilton Depression Rating Scale) in 30 days when taking adjunctive Deplin 15mg compared to antidepressant alone.
In an analysis looking at secondary genomic and biomarker endpoints, it was noted that a numerically greater treatment effect was observed in patients with an allelic variant in the methylenetetrahydrofolate reductase (MTHFR) C677T genotype. The difference in mean change between L-methylfolate and placebo was nearly twice that of patients without the genetic variant on both the 28-item Hamilton Depression Rating Scale (HDRS-28) (-3.75 vs. -1.99) and the Clinical Global Impression of Severity Scale (CGI-S) (-0.774 vs. -0.427).
Furthermore, patients with a body mass index of 30 kgm2 or greater also experienced a significantly greater reduction in depressive symptoms following treatment with L-methylfolate -- a difference in mean change in HDRS-28 of -4.66.
The findings represent a "consistent signal suggesting that something is going on with respect to the metabolic, inflammatory, and oxidative profile of some patients that renders them particularly susceptible to the therapeutic effects of L-methylfolate as adjunctive therapy above and beyond placebo," said Dr. Papakostas, though he stressed that confirmatory trials are needed.
Study participants were outpatients who had no response, or only a partial response, to SSRIs. The multicenter trial used a novel sequential parallel comparison design, and was thus divided into two 30-day phases. In addition to their SSRI treatment, patients were randomized to receive either adjunctive L-methylfolate for 60 days, placebo for 30 days followed by L-methylfolate for 30 days, or placebo for 60 days. Results from each phase were then pooled in the final analysis.
“Emerging developments in the understanding of depression now strongly point to biomarkers and genotypes as important variables in how patients respond to their depression treatment,” said Dr. Jain. “Exciting new data supports that L-methylfolate augmentation of standard antidepressants may better address these genetic and inflammatory factors in the management of depression. This heralds the dawn of a new type of personalized medical care in psychiatry.”
Data Source: A post hoc analysis of data from a double-blind, placebo-controlled, parallel-sequential study of 75 patients with SSRI-resistant MDD.
About Pamlab, LLC
Pamlab is a specialty biomedical company that specializes in -personalized medicine by offering health care providers high quality prescription medical foods to safely address the underlying metabolic dysfunction of patients suffering from a medical condition.
About Deplin
Deplin® is a medical food containing L-methylfolate, the active form of folate. It is the form of folate that crosses the blood-brain barrier to regulate neurtransmitters that affect mood (serotonin, norepinephrine and dopamine).
Deplin® provides the body with the necessary nutritional support to make the brain a better “partner” to the antidepressant a healthcare provider has prescribed.
About Medical Foods
The Orphan Drug Amendments of 1988 define “medical food” as a food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
Deplin® is a registered trademark of Pamlab, LLC
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