New treatment shows promising improvements for women with postpartum depression

Samantha Meltzer-Brody, MD, MPH, director of the Perinatal Psychiatry Program at the School of Medicine and the Ray M. Hayworth Distinguished Professor in Mood and Anxiety Disorders, led the three clinical trials leading up to the FDA approval of the first treatment of postpartum depression. UNC Health Care was a study site for these trials, supported by our TraCS Clinical and Translational Research Center (CTRC) nursing staff. In the most recent Phase 3 trial, study participants were admitted to the Perinatal Psychiatry Inpatient Unit (PPIU) while CTRC nursing staff traveled to the PPIU to conduct study dosing visits. Additionally, study screening and follow-up visits were conducted in the CTRC outpatient unit.

After three clinical trials led by a Carolina researcher, a new injection has been approved by the U.S. Food and Drug Administration to treat postpartum depression.

The drug, ZULRESSO (brexanolone), showed rapid reduction in depressive symptoms during clinical trials, making it the first and only treatment specifically indicated to treat postpartum depression in women.

Principal investigator Samantha Meltzer-Brody of the UNC School of Medicine said the FDA approval marks a major step forward in women’s healthcare.

“FDA approval of a drug that was developed specifically for postpartum depression is a game-changer for women’s health,” said Meltzer-Brody, director of Perinatal Psychiatry Program at the School of Medicine and the Ray M. Hayworth Distinguished Professor in Mood and Anxiety Disorders. “Given the results of the ZULRESSO clinical trials, we believe that this will be an important treatment option which could provide relief for women with PPD, a disorder with a range of postpartum severity.”

Common symptoms of postpartum depression – a mood disorder in women that can be triggered by fluctuations in reproductive hormones – include low mood, feeling overwhelmed, anxious and ruminating thoughts, potential withdrawal from the baby and her family, and suicidal thoughts in the most severe cases. Postpartum depression is one of the most common complications of pregnancy, with one in nine mothers in the U.S. experiencing it.

Compared with other medications that treat depression, ZULRESSO helped new mothers feel better faster during clinical trials.

“With current anti-depressant SSRIs (selective serotonin reuptake inhibitors) it could take four to six weeks to get a treatment response,” said Meltzer-Brody. “The weeks and months following birth are a critical period for mother-infant bonding, so finding a quick-acting treatment is crucial for both mom and baby. In the trials with ZULRESSO, we saw patients starting to feel better within days.”

The trials took place at 30 sites in the U.S., including Carolina’s Perinatal Psychiatry Unit, which was the first and only site to initially administer the drug in the open-label trial and participate in the full clinical trial program.

Eligible trial participants included women age 18-45 years old who were six months postpartum or less at screening and had onset of symptoms during pregnancy or within four weeks of delivery. They also had to be experiencing moderate to severe postpartum depression, which was assessed by the Hamilton Depression Rating Scale.

Participants saw a statistically significant reduction in depression severity that lasted throughout the last day of the study visit at Day 30.

Dr. David Rubinow, chair of the psychiatry department at the School of Medicine and one of the coauthors of the published results, said, “As long as I’ve been in this field, I don’t believe I’ve ever seen results quite as dramatic as those from this program.”

“This is a very different model for how we treat depression,” Meltzer-Brody said. “Having a drug approved to treat PPD that works quickly and effectively, yet is also durable, is a huge step forward for psychiatry in general.”