ORLANDO, Fla. — EnBrace HR, a novel nutritional prenatal supplement containing methylfolate, was well-tolerated and showed potential efficacy in preventing and treating perinatal depression, according to data presented at Psych Congress.
“We often see patients who are either planning pregnancy or are pregnant who want to stop taking or minimize the use of prescription medication for psychiatric reasons during pregnancy,” Marlene P. Freeman, MD, from the psychiatry department and the Center for Women’s Mental Health at Massachusetts General Hospital, told Healio Psychiatry. “We see many women with histories of major depressive disorder who are either planning pregnancy or are pregnant who have been doing well when treated with medication, but there’s a high rate of relapse when individuals who are treated with antidepressants stop taking them.”
In this preliminary, 12-week open-label study, researchers examined EnBrace HR (JayMac Pharmaceuticals, LLC) — a prescription prenatal/postnatal dietary management product containing 5.53 mg L-methylfolate, 1 mg folic acid and 2.2 mg folinic acid — for depression relapse prevention and treatment of major depression in pregnant women (less than 28 weeks), or women who are planning pregnancy, with histories of MDD.
Participants were in one of two groups: the first group was a relapse prevention group and included 11 participants without depressive episodes who planned to discontinue antidepressant treatment for pregnancy, and group two included six participants with depression at baseline. The goal for group 1 was to remain well – assessing EnBrace for depressive relapse prevention, and the goal for group 2 was to assess whether EnBrace appeared efficacious for acute depression.
The investigators used the Mini International Neuropsychiatric Interview to assess MDD relapse and the Montgomery-Asberg Depression Rating Scale (MADRS) to assess depressive symptoms. They also collected biomarkers of folic acid metabolism and inflammation.
The results showed that the participants in group one, the relapse prevention group, experienced no significant reductions in MADRS score but saw lower rates of depressive relapse than expected, (27.3%; P = .005) when compared with participants in a previous study with history of MDD who discontinued antidepressants for pregnancy (67.7%). Women in group two, depressed at study entry, experienced significant improvement in MADRS scores (P = .001).
Furthermore, five of the six participants in group two saw improvements of more than 50% from baseline. A patient in group two remitted, relapsed, then again remitted before study completion, according to the data.
“This is a very promising study. The patients who entered generally did well and relapse was prevented. The patients, as a group, who entered with acute depressive episodes improved significantly throughout the course of this study,” Freeman said. “We know from a previous study of women during pregnancy that those who stopped medication had a relapse rate to major depressive episodes of about 68%, but the rate of relapse in this study was substantially lower than that.”
The investigators reported that one adverse event occurred. A woman in group one relapsed and was hospitalized for depression.
“The major limitations of the study were the small number — between the two groups, there were 19 patients — and that we did not have a control group, so all the patients received the study supplement,” Freeman told Healio Psychiatry. “We’re very excited about the possibilities of EnBrace for women with histories of depression who would like to minimize the use of antidepressants during pregnancy.” – by Savannah Demko
Freeman MP, et al. A prenatal supplement with methylfolate for the treatment and prevention of depression in women trying to conceive and during pregnancy. Presented at: Psych Congress; Oct. 25-28, 2018; Orlando, Fla.
Disclosures: Freeman reports research support from Alkermes, Forest/Actavis, JayMac, Otsuka, SAGE, Sunovion and Teva. As an employee of MGH, Freeman reports funding from Janssen, NIMH and SAGE. She also reports medical editing for GOED Newsletter and being part of the Independent Data Monitoring Committee at Janssen. JayMac, which provided the investigator-initiated grant to MGH and the study supplement, had no role in the study design.