Real-World Outcomes of Brexanolone to Treat Postpartum Depression.

BACKGROUND

While the efficacy of brexanolone, a U.S. Food and Drug Administration-approved infusion treatment for postpartum depression (PPD), has been demonstrated in controlled trials, few reports are available describing its real-world effectiveness.

METHODS

Leveraging real-world clinical data, the current report describes the characteristics and treatment outcomes of a sample of women (N = 150) receiving brexanolone treatment for PPD in a residential-style outpatient treatment center with up to 12 months of follow-up. The sample had a mean age of 30.0 years (SD = 4.5), with almost one-third (31.3%) on hormonal birth control, and most (91.3%) were taking concomitant psychiatric medications.

RESULTS

Participants reported significant decreases in depression and anxiety symptoms from pretreatment to posttreatment that were sustained across a 12-month follow-up. Edinburgh postnatal depression scale (EPDS) scores decreased from pretreatment (M = 19.9, SD = 4.1) to posttreatment (M = 10.5, SD = 4.5, p < 0.001, within-group effect size [Cohen's d] of 2.2). At 12 months follow-up, EPDS scores remained significantly lower among the retained subset of patients (N = 64, M = 9.2, SD = 6.5). Among a subset who underwent formal assessments for anxiety, scores on the perinatal anxiety screening scale decreased from pretreatment (M = 60.1, SD = 17.1) to posttreatment (M = 33.3, SD = 22.1, p < 0.01, within-group effect size of 1.4). Response and remission rates for depression were 68.7% and 46.7%, respectively, posttreatment, and 73.4% and 60.9%, respectively, at 12-month follow-up. Importantly, 15 participants had a diagnosis of bipolar depression and were prescribed an antipsychotic or mood stabilizer at the time of treatment, there were no episodes of mania or hypomania reported during the follow-up period.

CONCLUSIONS

Given the shared mechanism of action between brexanolone and the recently approved oral medication for PPD, zuranolone, the applicability of findings and relevance to the more accessible oral drug, zuranolone, are explored.