Clinical data previously reported in the American Journal of Psychiatry supported the benefits of the prescription medical food Deplin® (L-methylfolate) as an adjunct to antidepressants in a controlled trial of patients inadequately responding to Selective Serotonin Reuptake Inhibitors (SSRIs). Now, a study conducted to measure the real-world impact on 554 patients has found that those taking L-methylfolate reported a decrease in depression symptoms and approximately half achieved remission.
The study, "Assessing Effects of L-methylfolate in Depression Management: Results of a Real-World Patient Experience Trial," appears in the latest edition of The Primary Care Companion of CNS Disorders. This study sought to measure the change in depression symptoms and quality of life for depression patients, beginning with understanding how depression impacted patients' lives. From the trial participants, a full illustration was given of how depression made it harder to work, take care of things at home or get along with other people.
The study found key improvements at 12 weeks: participants reported a nearly 60 percent reduction in depressive symptoms from baseline; nearly half of patients achieved remission; and 74 percent fewer patients reported difficulty in daily functioning.
"This study followed the previous placebo-controlled clinical trial of l-methylfolate in treatment resistant major depression. However, there are always concerns about translating results from controlled clinical trials into real world clinical practice," said Dr. Richard Shelton, primary author and Charles B. Ireland Professor & Vice Chair for Research at the UAB School of Medicine. "This project involved 554 patients distributed across many practice sites. The level of improvement shown by participants in this study supports the benefit of l-methylfolate in patients that clinicians see in their practice."
Data for this open-label study was obtained between November 2010 and April 2012. Patients being treated for major depression rated their experiences at baseline, 6 weeks and 12 weeks, on Deplin 7.5 or 15 mg, through an automated telephone system. The survey included the Patient Health Questionnaire (PHQ-9), a nine-item, self-reported, validated metric scale that is also used by clinicians to diagnose the condition. Of the participants, 502 (91 percent) reported Deplin was added to their existing antidepressant and 52 (nine percent) received Deplin monotherapy.
Patient medication compliance was positive, with over 90% of patients reporting taking every dose or nearly every dose of l-methylfolate.