MedicalResearch.com Interview with:
Samantha Meltzer-Brody, MD, MPH
Associate Professor and Associate Chair for Faculty Development
Director, Perinatal Psychiatry Program
Director, Taking Care of Our Own Program
Department of Psychiatry
Chapel Hill, NC 2759
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Lancet published results from a randomized, placebo-controlled, phase 2 clinical trial with the investigational medication, brexanolone, for women with severe postpartum depression (PPD). During the study, which was conducted at multiple sites across the country, physician researchers administered brexanolone in 21 women, 10 of whom were administered a 60-hour infusion of brexanolone. The other 11 women were given a placebo. Results from the trial showed that 70 percent of participants who received the drug saw remission of their PPD symptoms within 60 hours of treatment, an effect that was maintained until the 30-day follow up.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: Currently, there are no drugs specifically indicated to treat postpartum depression, which affects an estimated 10 to 20 percent of all mothers in the US who give birth. It is critical that we develop a treatment specifically for women suffering from postpartum depression.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Based on the positive results of the Phase 2 study, we are continuing to investigate brexanolone for its potential use in the treatment of postpartum depression.
MedicalResearch.com: Is there anything else you would like to add?
Response: I want to emphasize that postpartum depression is a common condition. It is a biological complication of childbirth affecting an estimated 10-20% of women in the US. Symptoms can begin as early as the beginning of the third trimester or in the acute postpartum period and may persist well beyond the perinatal period if untreated. It is important that healthcare providers proactively screen women for postpartum depression, and furthermore, provide these women with necessary support. Feelings of guilt, shame or fear can be significant barriers that prevent women from speaking up about their symptoms, so it is essential for clinicians to encourage open and honest conversations about this condition.
Disclosures: Sage Therapeutics sponsored the study. Dr. Meltzer-Brody through the University of North Carolina at Chapel Hill receives research grant support for this study
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Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial
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