12-Week Study of Metabolic Management with Deplin® Finds Statistically Significant Improvement in Depression Symptoms and Daily Functioning
COVINGTON, La. September 23, 2013 – 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.
Pamlab, founded in 1987, is a specialty biomedical company that specializes in offering high quality prescription medical foods to safely and effectively address the distinct nutritional requirements of patients with specific medical conditions. Pamlab investigates nutritional science and promotes evidence which can direct effective disease management for brain health (depression and memory loss) and metabolic conditions (diabetes). Pamlab, part of Nestlé Health Science since April 2013, employs around 450 people in the United States and is based in Covington, Louisiana. More information is available at www.pamlab.com.
About Nestlé Health Science
Nestlé Health Science, a wholly-owned subsidiary of Nestlé, intends to spearhead the development of science-based personalized nutritional solutions. Building on its core HealthCare Nutrition business, the company has ambitions to address chronic conditions in the area of Gastrointestinal Health, Metabolic Health and Brain Health. Nestlé Health Science offers nutritional solutions for people with specific dietary needs related to illnesses, disease states or the special challenges of different life stages. Nestlé Health Science employs around 3,000 people worldwide and has its headquarters in Vevey, Switzerland.