Potential Treatment Option for Women Deciding to Discontinue Antidepressants During Pregnancy

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Massachusetts General Hospital Efficacy Study Centers on EnBrace HR

Pregnant Woman Suffering With Major Depressive Disorder

Many women attempt to stop antidepressants for pregnancy, and without good alternative options, many of those women will suffer a relapse of depression.

We are excited to study treatment options for depression, other than standard antidepressant medications, because it is important to be able to offer a range of treatments to women with depression during pregnancy. - Marlene Freeman, MD

JayMac Pharmaceuticals is sponsoring a study at Massachusetts General Hospital to assess the efficacy of a pre-and post-natal supplement, EnBrace HR™, as a treatment for the prevention of depression in women with a history of Major Depressive Disorder who decide to discontinue their maintenance antidepressant drug treatment for pregnancy.

“Many women attempt to stop antidepressants for pregnancy, and without good alternative options, many of those women will suffer a relapse of depression,” said Marlene Freeman MD, Associate Professor of Psychiatry, Harvard Medical School and Associate Director, Center For Women’s Mental Health, Massachusetts General Hospital, who is the study’s Principal Investigator.

Major depressive disorder occurs twice as often in women compared to men, substantially affecting women of childbearing years. As well, that 20% of women experience an episode of depression in their lifetimes. Therefore, identifying safe and effective treatments for depression before, during, and after pregnancy has become a critical public health issue.

“We are excited to study treatment options for depression other than standard antidepressant medications, “ said Dr. Freeman, “because it is important to be able to offer a range of treatments to women with depression during pregnancy. “

About EnBrace HR™
EnBrace HR™ (FDA IND# 129890) is a once a day, prescription prenatal/postnatal dietary supplement that contains vitamin coenzymes, mineral cofactors, and a unique Omega 3 phospholipid. It includes L-methylfolate, folinic acid, reduced folates, and is optimal for a population with high rates of MTHFR Polymorphism that affect folic acid metabolism. Along with reduced folates it contains omega 3 fatty acids primarily EPA, which shows promise for the treatment of depression. Importantly, these components are crucial for healthy pregnancies. Folates supplementation has been associated with reduced risk of neural tube defects and is recommended for use in women of reproductive potential to reduce the risks of birth defects. L-Methylfolate compounds, such as EnBrace HR, may provide a more efficient delivery of folate-related compounds to this end. EnBraceHR.com

More About Marlene Freeman, MD:
https://womensmentalhealth.org/staff/marlene-p-freeman-md/

About Massachusetts General Hospital:
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $800 million. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals, earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2016 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America’s Best Hospitals." http://www.massgeneral.org/

About JayMac Pharmaceuticals:
JayMac Pharmaceuticals is a privately held pharmaceutical company based in Sunset, Louisiana with a strong history providing acute-care pharmaceuticals across specialties. Current flagship products are FDA-regulated folate therapies, EnLyte and EnBrace HR.

Study Detail Found On ClinicalTrials.Gov:
https://clinicaltrials.gov/ct2/show/record/NCT02676882

Please refer to this study by its ClinicalTrials.gov identifier: NCT02676882

To Join the Study - Patient Contact:
Gina M Savella
617-643-9284
gsavella(at)partners(dot)org

MEDIA CONTACT:
Sheilah Griggs
917.791.0321

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Sheilah Griggs
SG Enterprises
+1 (310) 871-9592
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