Women with severe postpartum depression may experience improvements within a few days of taking the oral medication zuranolone (a neuroactive steroid), suggests a report published today in The American Journal of Psychiatry. These improvements continued even after the women stopped the 14-day medication regimen.
The study was funded by Sage Therapeutics and Biogen, which are involved in the development of the medication.
Postpartum depression affects an estimated 17% of women worldwide, according to Kristina M. Deligiannidis, M.D., of Zucker Hillside Hospital and colleagues. This disorder can lead to multiple challenges for mothers and infants, including poor maternal-infant bonding, increased risk of infant behavioral problems, and suicidal ideation in mothers. “Current treatment options often include standard-of-care antidepressants; however, achieving response to treatment can take up to 12 weeks,” Deligiannidis and colleagues wrote. “Given the deleterious effects of untreated [postpartum depression], identification of rapid and effective treatment options is critical.”
Zuranolone is a rapid-acting medication in development for the treatment of postpartum depression; it has been granted priority review by the Food and Drug Administration. A previous trial found zuranolone at the 30 mg/day dose to be effective and generally well tolerated.
For the current phase 3 trial, 196 women aged 18 to 45 with severe postpartum depression were randomized to zuranolone (50 mg/day) or placebo pills for 14 days. To be included in the trial, the participants had to have a baseline score of at least 26 on the 17-item Hamilton Depression Rating Scale (HAM-D), experienced a major depressive episode with onset during the third trimester of pregnancy or up to four weeks after giving birth, and were within the postpartum period of 12 months or less. The researchers evaluated the participants using multiple assessments over the course of the 45-day trial, including the HAM-D total score, Clinical Global Impressions severity (CGI-S) score, Hamilton Anxiety Rating Scale (HAM-A), 9-item Patient Health Questionnaire (PHQ-9), and more.
“Patients receiving zuranolone demonstrated robust, clinically meaningful, and rapid improvements in depressive symptoms, as assessed by change from baseline HAM-D score, which were evident as early as day 3 and were maintained through day 45,” Deligiannidis and colleagues wrote. The women also showed improvements in anxiety and symptom severity from baseline to day 15.
The most common side effects reported by patients were somnolence, dizziness, sedation, and headache.
“Given the prevalence and substantial adverse maternal and infant outcomes associated with [postpartum depression], its appropriate management is essential,” Deligiannidis and colleagues wrote. “Therefore, if approved, zuranolone would be the first short-course, rapid-acting, oral treatment for patients with PPD.”
For related information, see the Psychiatric News article “Perinatal Treatment Requires Careful Risks, Benefit Consideration.”
