Zuranolone significantly improves symptoms of postpartum depression

Key takeaways:

• Women on zuranolone experienced statistically significant improvement in depressive symptoms at day 15 vs. those on placebo.
• The most common adverse events included somnolence, dizziness and sedation.

The investigational neuroactive steroid zuranolone was generally well-tolerated and demonstrated significant improvement in symptoms in women with postpartum depression, according to a study published in The American Journal of Psychiatry.

“Postpartum depression is underrecognized, undertreated and disruptive for those who live with the condition,” study author Kristina M. Deligiannidis, MD, director of Women’s Behavioral Health at Zucker Hillside Hospital and associate professor at Feinstein Institutes for Medical Research, said in a press release from Feinstein. “We collaborate with researchers around the world in an effort to develop more rapid and effective therapies for the many women who need support.”

In the phase 3, placebo-controlled, double-blind SKYLARK study, Deligiannidis and colleagues randomized 196 women with severe postpartum depression to receive once-daily zuranolone 50 mg or placebo for 14 days.

Researchers used the 17-item Hamilton Depression Rating Scale (HAM-D) to measure change from baseline in total score at days 3, 15, 28 and 45, as well as change in Clinical Global Impressions severity (CGI-S) score at day 15.

According to results, participants taking zuranolone (n = 98) had statistically significant improvement in depressive symptoms at day 15 compared with those on placebo (least squares mean change from baseline in HAM-D, –15.6 vs. –11.6; difference = –4; 95% CI, –6.3 to –1.7). Researchers noted similar improvement in symptoms at days 3, 28 and 45, as well as improvement in CGI-S scores at day 15.

The most common adverse events, reported in at least 5% of participants in the zuranolone group, included somnolence, dizziness, sedation, headache, diarrhea, nausea and urinary tract infection.

“We have been working on neuroactive steroid research in postpartum depression for nearly 15 years,” Deligiannidis said in the release. “The SKYLARK study follows previous successful clinical trials, and publishing its results is a pinnacle moment in treating postpartum depression.”

Reference:

• Novel investigational postpartum depression pill, zuranolone, shows rapid, significant improvement in depressive symptoms in phase 3 clinical trial. https://feinstein.northwell.edu/news/the-latest/zuranolone-shows-significant-improvement-in-depressive-symptoms-in-trial. Published July 25, 2023. Accessed July 31, 2023.