Feinstein Institute’s Institute of Behavioral Science professor Dr Kristina Deligiannidis Dr Kristina Deligiannidis led the trial. Credit: Feinstein Institutes.

The Feinstein Institutes for Medical Research at Northwell Health in the US has reported that zuranolone (50mg) offered symptom improvement in patients with postpartum depression (PPD) in the Phase III SKYLARK clinical trial.

The trial enrolled 200 female subjects aged between 18 and 45 years, with postpartum major depressive episodes, who were given either zuranolone or a placebo.

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An investigational neuroactive steroid pill for PPD treatment, zuranolone was administered orally once a day for 14 days in the at-home setting. 

The depressive symptoms of the trial subjects were analysed at various time points for 45 days. 

According to the findings from the placebo-controlled trial, patients who received zuranolone were found to have quick, clinically meaningful, and statistically significant improvements in depressive symptoms at various time points. 

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At day 15, zuranolone offered an improvement of 50% or more in depressive symptoms in 57% of the subjects, compared to 38% in the placebo arm. 

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The figure stood at 61.9% of the women in the zuranolone arm versus 54.1% for the placebo at day 45. 

Improvements were observed in trial subjects by day three and lasted through to day 45.

Somnolence, dizziness, sedation, and headache were reported to be some of the most frequent treatment-emergent adverse events reported in the trial.

Feinstein Institute’s Institute of Behavioral Science professor and trial lead Dr Kristina Deligiannidis said: “We have been working on neuroactive steroid research in PPD for nearly 15 years. 

“The SKYLARK study follows previous successful clinical trials, and publishing its results is a pinnacle moment in treating postpartum depression.” 

This data is said to back the potential US Food and Drug Administration (FDA) approval for zuranolone as the first-of-its-kind PPD treatment.