CLINICAL TRIAL: A prenatal supplement with methylfolate for the treatment and prevention of
Updated: Jan 24
Women often seek antidepressant alternatives for major depressive disorder in anticipation of or during pregnancy
BACKGROUND: Women often seek antidepressant alternatives for major depressive disorder (MDD) in anticipation of or during pregnancy. In this preliminary study, EnBrace HR, a prenatal supplement containing methyl folate, was investigated for depressive relapse prevention and for acute treatment of MDD in women planning pregnancy or during pregnancy.
METHODS: This 12week openlabel study included women with histo ries of MDD who were planning pregnancy or pregnant <28 weeks. At enrollment, Group 1 participants were well (not depressed) and planned to discontinue antidepressants for pregnancy. Group 2 participants were depressed. Primary outcome variables by group included MDD relapse and depressive symptoms, verified with the MiniInternational Neuropsychiatric Interview and the MontgomeryÅsberg Depression Rating Scale (MADRS), respectively. Biomarkers of inflammation and the folate cycle were collected.
RESULTS: Group 1 participants (N = 11) experienced lower rates of depres sive relapse (27.3%; P = .005) than expected from a historical comparison group and no significant changes in MADRS scores. Group 2 participants (N = 6) experienced significant improvements in MADRS scores (P = .001), with 5 (83.3%) improving >50% and 1 improving 33.3%. One adverse event occurred, a hospitalization for depression.
CONCLUSIONS: Results suggest EnBrace HR is a welltolerated intervention with potential efficacy for prevention and treatment of perinatal depres sion. Larger controlled trials are necessary.