CLINICAL TRIAL: A prenatal supplement with methylfolate for the treatment and prevention of

Women often seek antidepressant alternatives for major depressive disorder in anticipation of or during pregnancy

Clinical-Study-Freeman-EnBrace-HR

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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 open ­label study included women with histo­ries 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 depres­sive 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 well­-tolerated intervention with potential efficacy for prevention and treatment of perinatal depres­sion. Larger controlled trials are necessary.