HealthDay News — For women with severe postpartum depression (PPD), zuranolone yields significant improvements in depressive symptoms, according to a study published online July 26 in The American Journal of Psychiatry.
Kristina M. Deligiannidis, M.D., from the Feinstein Institutes for Medical Research at Northwell Health in Manhasset, New York, and colleagues conducted a double-blind phase 3 trial involving women with severe PPD who were randomly assigned to receive zuranolone or placebo for 14 days (98 patients to each). Of the participants, 86.7% completed the 45-day study.
Researchers found that compared with placebo, treatment with zuranolone resulted in statistically significant improvement in depressive symptoms at day 15 (least squares mean change from baseline in 17-item Hamilton Depression Rating Scale, −15.6 vs −11.6); at days 3, 28, and 45, significant improvements in depressive symptoms were also reported. At day 15, the Clinical Global Impressions severity score significantly improved with zuranolone vs placebo. Somnolence, dizziness, and sedation were the most common adverse events with zuranolone (≥10%). There was no loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior reported.
“Standard-of-care antidepressants often must be taken chronically and generally require weeks to months to take effect, leading to substantial morbidity,” the authors write. “Therefore, if approved, zuranolone would be the first short-course, rapid-acting, oral treatment for patients with PPD.”
Several authors disclosed ties to biopharmaceutical companies, including Sage Therapeutics and Biogen, which manufacture zuranolone and funded the study.