MANHASSET, NY —
An investigational drug demonstrated a reduction in depressive symptoms in women suffering from severe postpartum depression (PDD), a potentially significant development for the one in seven women in the United States who are afflicted, according to clinical trial data published in the prestigious journal The Lancet. The publication of findings from this multi-site, phase 2a double-blind, placebo-controlled trial, announced today by Northwell Health's Feinstein Institute for Medical Research and Sage Therapeutics Inc., is the first placebo-controlled clinical trial to examine the use of brexanolone (SAGE-547) as a treatment for severe postpartum depression.
Postpartum depression is a severe, long-lasting form of depression that can begin anywhere from a few days to six months after giving birth. For some women, symptoms begin during pregnancy and worsen after delivery. Women with depression post pregnancy can experience a variety of symptoms, including depressed mood or severe mood swings, difficulty bonding with their child, withdrawal from family and friends, thoughts of suicide and fear of not being a good mother. These symptoms experienced by the mother can also have an impact on her child as well, affecting the child's temperament, cognitive and social development.
Previous studies have demonstrated that rapid fluctuations in reproductive hormones during pregnancy and immediately after a woman gives birth may be associated with the development of postpartum depression. This current study aimed to test whether brexanolone could decrease the symptoms in women with severe postpartum depression.
"Severe postpartum depression can be a difficult condition to treat, with many women not achieving full remission of symptoms," said Kristina M. Deligiannidis, MD, co-author of the study and associate professor at the Feinstein Institute for Medical Research and director of Women's Behavioral Health at Zucker Hillside Hospital. "The positive results of this clinical trial indicate that brexanolone may have potential as a novel treatment option for PPD."
In this study, 10 women exhibiting the signs of severe postpartum depression were administered brexanolone intravenously for 60 hours and then were monitored immediately after IV treatment stopped, then periodically from two hours up to 30 days. Eleven patients were administered a placebo and monitored during the same timeframe. At the end of the 60-hour infusion, average reduction in patients' Hamilton Rating Scale for Depression (HAM-D or depression rating) was 21 points in the brexanolone group, versus eight in the placebo group. Seven of the 10 patients receiving brexanolone achieved remission from depression after the 60-hour infusion with only one in the placebo group. This reduction of symptoms in the patients receiving brexanolone was maintained during the 30-day study.
Brexanolone was generally well tolerated. There were no deaths, serious adverse events, or discontinuations. The most commonly reported adverse events in the brexanolone group were dizziness (two brexanolone-treated subjects; three placebo-treated subjects) and somnolence (two brexanolone-treated subjects; zero placebo-treated subjects) and an equal number of patients reported the cluster of dizziness, sedation or somnolence (three in brexanolone group and three in the placebo group).
Steve Kanes, MD, PhD, chief medical officer of Sage Therapeutics, is the lead author of the paper. As a continuation of this study, Sage Therapeutics is currently conducting larger multi-site phase 3 clinical trials of brexanolone in moderate and severe postpartum depression at several major academic medical centers across the United States, including the Feinstein Institute for Medical Research and Zucker Hillside Hospital.
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About the Feinstein Institute
The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in New York. Home to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the Feinstein includes 4,000 researchers and staff who are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org.
Heather E. Ball