Efectividad de la zuranolona con relación al placebo en el tratamiento de la depresión postparto. Revisión sistemática

Abstract

Background: Postpartum depression is categorized by the American Psychiatric Association (DSM-5, Diagnostic and Statistical Manual of Mental Disorders) as a "depressive disorder with peripartum onset" and has a global incidence of 17.2%, which represents between 600,000 to 800,000 cases annually and is associated with significant risks of suicide and filicide. Approximately 20% of postpartum deaths are due to suicide; furthermore, it was observed that mothers were involved in 71.7% of infanticide cases in 12 countries and were responsible for 100% of neonaticide cases in 13 countries. Objective: To determine the effectiveness of zuranolona in the treatment of postpartum depression, approved by the FDA (Food and Drug Administration). Methodology: Systematic review of a retrospective, descriptive, and qualitative type of studies published in English and Spanish. Results: In six clinical trials with 863 participants, zuranolone showed a significant improvement in depressive and anxiety symptoms from day 3 (p=0.03) to day 45 (p=0.003). With 30 mg, remission on the Hamilton Rating Scale for Depression was OR 2.63 (95% CI: 1.34-5.16; p≤0.003), while, with 50 mg, it reached OR 1.78 (95% CI: 0.88-3.62; p≤0.007), suggesting greater efficacy with higher doses. A phase 1 study with 14 participants confirmed that zuranolone has low transfer into breast milk with a Relative Infant Dose (RID) of 0.357%, making it compatible with breastfeeding. The findings support its rapid and sustained effectiveness, although higher doses may increase adverse effects such as sedation and dizziness. Keywords: postpartum depression, zuranolone, placebo