Pamlab reported that new data from two studies affirm the long-term value of Deplin (L-methylfolate), a medical food, for the nutritional management of metabolic imbalance in patients with major depressive disorder (MDD). The data also showed that greater treatment effects may be seen in certain subsets of patients, such as those with the methlentetrahydrofolate reductase (MTHFR) genetic variant or with a body mass index (BMI) ≥30.
In a 12-month, open-label study, 13 patients received Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) and were evaluated every 12 weeks. No patients experienced relapse at any time point and seven patients (54%) maintained full remission at 12 months.
A second multicenter, double-blind, randomized, placebo-controlled study evaluated the effects of specific metabolic biomarkers including BMI and MTHFR in 75 patients with SSRI-resistant MDD receiving Deplin. Compared with placebo, a greater treatment effect was observed in patients given Deplin 15mg in addition to their SSRI who had an allelic variant in the MTHFR C677T genotype. Differences in mean changes in Hamilton Depression Rating Scale (HDRS)-28 were -3.75 for patients with a “T” allele (homozygote and heterozygote alleles combined) versus -1.99 for the patients with a “CC” allele (considered the “normal” allele) and marginally significant (P=0.087). Greater efficacy was also observed in patients with a BMI ≥30. Differences in mean changes in HDRS-28 was +0.99 for BMI <30 and -4.66 for BMI ≥30. The difference for depressed individuals with BMI ≥ 30 was strongly significant (P=0.001).
Deplin is a medical food available by prescription for the clinical dietary management of the metabolic imbalances associated with depression.
For more information visit www.deplin.com.