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Feinstein Institutes: Drug for postpartum depression showing positive results

Dr. Kristina Deligiannidis, associate professor at the Feinstein

Dr. Kristina Deligiannidis, associate professor at the Feinstein Institutes for Medical Research in Manhasset, was the principal investigator on the clinical trial. Credit: The Feinstein Institutes

A new drug designed to help women battling postpartum depression has shown positive results in a clinical trial run by the Manhasset-based Feinstein Institutes for Medical Research, according to scientists.

Scientists said that just two weeks after taking 30 milligrams of zuranolone, an oral neuroactive steroid, 45% of participants were depression-free.

This result is in stark contrast to existing antidepressant medications, which might not yield full benefits for eight to 12 weeks, said Dr. Kristina Deligiannidis, associate professor at the Feinstein Institutes and principal investigator on the clinical trial.

What to know

The clinical trial of zuranolone for postpartum depression  — conducted by the Feinstein Institutes for Medical Research — has shown positive results, according to scientists.

The trial included 153 randomized patients at 27 centers across the country. Participants were women between the ages of 18 and 45 with perinatal major depressive episodes.

The women received either 30 milligrams of zuranolone or a placebo once a day for 14 days. Researchers monitored participants for 45 days.

At day 45, researchers found 53% of women who took the drug were depression-free as opposed to 30% who took the placebo.

"We saw really rapid improvements in depression as soon as Day Three," Deligiannidis said. "And these sustained improvements were all the way out through the end of the study at Day 45."

The findings, recently published in the Journal of the American Medical Association Psychiatry, could be a major step in treating an illness that impacts scores of women every year, yet is still shadowed by stigma.

Research by the U.S. Centers for Disease Control and Prevention shows that about 1 in 8 women experience symptoms of postpartum depression after giving birth, ranging from sleeplessness, long bouts of crying and loss of appetite, to low self-worth, trouble bonding with their babies, and no motivation to care for themselves or their babies.

"There’s this expectation in society that you have a baby and you feel bonded immediately, and that's not true for all women," said Dr. Jessica Cosgrove, physician-in-charge of the Perinatal Psychiatry Center at Zucker Hillside Hospital in Queens. "And then, especially for women who have episodes of postpartum depression, they can feel a lot of guilt around that."

In some extreme cases, she said, women with postpartum depression could have suicidal thoughts.

"About 10% to 15% of women will have postpartum depression, and it's likely underestimated because women don't seek treatment," Cosgrove said.

The one FDA-approved medication for postpartum depression, brexanolone, must be administered intravenously over a period of 60 hours.

If zuranolone is eventually approved by the Food and Drug Administration, it would be groundbreaking, experts said. It still must undergo more clinical tests.

Deligiannidis said spending 60 hours in a hospital or another setting to receive an infusion of brexanolone is challenging for many women.

"Many women may not have the child care support to care for their children and families that is needed to go into the hospital for this kind of treatment," she said. "There’s a need to develop treatments that work quickly and that women can take on their own."

Parent says she felt fear, panic attacks

When Kaitlin Drummond, of Williston Park, gave birth to her baby boy at the height of the COVID-19 pandemic, the joyful moment was overshadowed by fear, panic attacks and obsessive thoughts that she would not be able to properly care for him.

"I felt like every feeding and nap needed to be perfect or we would spiral down into irreversible chaos," she said. "Little everyday hiccups that are just part of a day in the life of a baby seemed like life or death to me. I became so anxiously obsessive about all the things having to do with the safety and enrichment of my baby that I forgot how to care for myself."

She sought help when her son was 3 months old, but it took months of individual and group therapy to regain her sense of self and confidence in being a mother.

"This medication sounds like the ‘silver bullet’ that I was desperately seeking at the peak of my perinatal mood and anxiety disorder that all of the specialists I was working with said didn’t exist," Drummond said.

The clinical trial included 153 randomized patients at 27 centers across the country. All of the participants were women between the ages of 18 and 45 with perinatal major depressive episodes. They received either 30 milligrams of zuranolone or a placebo once a day for 14 days. Researchers monitored participants for 45 days.

The drug, developed by Cambridge, Massachusetts-based Sage Therapeutics, is a modified version of a neurosteroid naturally made in the human body that reduces stress, Deligiannidis said.

At day 45, researchers found 53% of women who took the drug were depression-free as opposed to 30% who took the placebo.

Deligiannidis's research group at the Feinstein Institutes, the research division of Northwell Health, is currently recruiting women for a clinical trial to test 50 milligrams of the drug in postpartum depression.

"Women often do everything for everyone else and neglect their own health," she said. "We want to empower women to take charge of their health, including their emotional health … we have effective treatments, and we’re working on even better ones for them."

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