Open-label study of the efficacy, safety and tolerability of Brexanolone in the treatment of adult women with postpartum psychosis

OBJECTIVE: Postpartum psychosis (PPP) is a rare but severe postpartum psychiatric emergency that occurs during a critical time in mother-infant attachment. This study investigated the efficacy, safety, and tolerability of brexanolone, a neuroactive steroid and synthetic form of allopregnanolone, for adult females with PPP. METHODS: In this open-label, proof-of-concept study, ten patients with PPP received brexanolone as a single, continuous, 60-h intravenous infusion titrated to a target dose of 90 μg/kg/h over a period of 2.5 days. Primary outcomes were change in total score on the Young Mania Rating Scale (YMRS) and Positive and Negative Syndrome Scale (PANSS); Secondary outcomes included change in Hamilton Depression Rating Scale (HAMD) from baseline to Day 7. Adverse events were monitored. Patients were followed through Day 90. RESULTS: All ten patients completed the treatment protocol without dose reductions and without intolerable adverse side effects. Change in mean PANSS total score from baseline to Day 7 was statistically significant (p = 0.00006; 95 % CI [19.60-38.40]), as were YMRS scores (p = 0.01; 95 % CI [2.69-16.01]) and HAM-D scores (p = 0.0003; 95 % CI [5.22-11.98]). CONCLUSIONS: This study suggests the potential for neuroactive steroids as rapid-acting, adjunctive treatment for PPP and provides support for future research to assess the role of neuroactive steroids and synthetic forms of allopregnanolone in the treatment of PPP.