New research that finds links between biological and genetic markers and improved response to L-methylfolate as an augmentation therapy for major depressive disorder (MDD) is the focus of three presentations at this year’s American Psychiatric Association (APA) and Society of Biological Psychiatry (SOBP) annual meetings.
MDD can include certain metabolic conditions associated with poor response to Selective Serotonin Reuptake Inhibitors (SSRI). A study recently published in the American Journal of Psychiatry (December 2012) examined L-methylfolate 15mg as an adjunct to SSRIs compared to adjunctive placebo. Co-primary endpoints included response (50% reduction) and degree of reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HDRS). Secondary and exploratory endpoints included treatment effect in patients stratified by genotypes and other biomarkers including obesity.
Two presentations at the SOBP annual meeting on May 16, and one at the APA annual meeting on May 22, presented data from this published study. 75 outpatients inadequately responding to an SSRI were enrolled in a 60-day study, divided into two, 30-day evaluation periods. Patients were randomized to receive L-methylfolate 15mg + SSRI for 60 days; placebo + SSRI for 30 days followed by L-methylfolate 15mg + SSRI for 30 days; or placebo + SSRI for 60 days. The SSRI doses remained constant during the double-blind phase of the study. Pooled 30 day results demonstrated significantly greater benefits in all-comers with adjunctive L-methylfolate 15mg + SSRI versus placebo + SSRI (continued SSRI monotherapy) according to Sequential Parallel Comparison Design (SPCD). Secondary genomic and biomarker endpoints were evaluated to determine if there was a difference in clinical response to adjunctive L-methylfolate 15mg in patients stratified by genotypes and obesity.