Background: Women who are pregnant or are planning pregnancy often seek alternatives to standard antidepressants (ADs) for the treatment of major depressive disorder (MDD). The objective was to obtain preliminary data for EnBrace HR, a prenatal supplement containing methylfolate, in 1) depressive relapse prevention for women who discontinue ADs, and 2) treatment for women in major depressive episodes (MDEs) who forgo AD treatment in this context.
Methods: This was a twelve-week open-label study of EnBrace HR in women with histories of MDD who were pregnant (<28 weeks) or planning to conceive. Group 1 participants were well at enrollment and planned to discontinue AD medication. Group 2 participants were depressed at enrollment. Mood symptoms were evaluated every two weeks. Primary outcome variables included MDE presence or absence, verified using the Mini International Neuropsychiatric Interview (MINI), and depression symptoms, monitored with the Montgomery-Ᾰsberg Depression Rating Scale (MADRS).
Results: Group 1 participants (N=13) experienced significantly lower rates of depressive relapse (23.1%; p=0.001) than historical rates in similar groups, and no significant changes in MADRS scores. N=1 participant was hospitalized for an MDD relapse, the only serious adverse event during the study. Group 2 participants (N=6) experienced significant improvements in depressive symptoms on the MADRS (p=0.001), with five (83.3%) improving >50% and one improving 33.3%.
Conclusions: While sample size was small, results suggest EnBrace HR is a well-tolerated intervention with potential for use in prevention and treatment of perinatal depression. Larger controlled trials are necessary to definitively determine efficacy.