OBJECTIVES : Postpartum depression (PPD) is a common, life-threatening condition affecting about 1 out of 10 women in the United States and can lead to impaired maternal functioning and child development. Brexanolone (BRX), a gamma-amino­butyric acid A receptor–positive modulator, is the first treatment to receive FDA approval specifically for women with postpartum depression. The objective of this review was to evaluate the efficacy and safety of BRX for the treatment of PPD by performing a meta-analysis

METHODS : MedLine, Embase and PsycINFO databases were searched via Ovid with no language or date restrictions. In addition, references of included studies and clinicaltrials.gov were manually searched for relevant studies. Inclusion criteria were randomized, placebo-controlled clinical trials on patients with PPD, BRX treatment, and derivable efficacy and safety outcomes. Study quality of included trials was assessed using the Cochrane Risk of Bias instruments. A meta-analysis using random effects model was conducted to calculate pooled effect estimates with 95% confidence intervals (CI) for change in scores of 17-item Hamilton Rating Scale for Depression (HAM-D) at 60 hours and adverse event rates

RESULTS : Three RCTs involving 247 patients were included. Compared to placebo, BRX infusion was associated with mean reduction of 2.2 (95% CI: -3.6, 8.0) in HAM-D total score from baseline, however the result was non-significant. The BRX arm showed no evidence of significant risk of total adverse events (Relative risk: 0.9; 95% CI: 0.4, 1.4) compared to placebo. Furthermore, Brexanolone was generally well tolerated. There were no deaths in all 3 trials and only 2 patients reported serious adverse events

CONCLUSIONS : Brexanolone showed substantial effect in the treatment of severe postpartum depression, for which there are no currently approved indications. Further high-quality RCTs and systematic reviews are required for conclusive determination of its effectiveness and tolerability compared to active comparators