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.