Title: Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial

Kanes, S. et al.


What You Need to Know:

According to findings of a phase 2 study, continuous infusion of brexanolone, a positive allosteric modulator of GABAA receptors, significantly reduces the Hamilton Rating Scale for Depression (HAM-D) total score in patients with severe post-partum depression compared to placebo.

Trial Design:

  • Double-blind, placebo-controlled, phase 2 study evaluated the efficacy of brexanolone in the treatment of post-partum depression
  • 21 female patients with severe post-partum depression (HAM-D score of 26) were randomly assigned (1:1) to receive one continuous, intravenous infusion of brexanolone (n=10) or placebo (n=11) over 60 hours
  • Primary endpoint: change in the HAM-D score from baseline to 60 hours
  • Patients were monitored until day 30

Key Outcomes:

  • “At 60 h, mean reduction in HAM-D total score from baseline was 20.1 points (SE 2.9) in the brexanolone group compared with 8.8 points (SE 2.8) in the placebo group (difference -12.2, 95% CI -20.77 to -3.67; p=0.0075; effect size 1.2)”
  • No deaths, serious adverse events, or discontinuations of treatment occurred in either group
  • 4/10 brexanolone patients experienced an adverse event vs 8/11 placebo patients
  • Most common adverse events: dizziness (2 brexanolone patients vs 3 placebo patients), somnolence (2 brexanolone patients vs 0 placebo patients)
  • Treatment-emergent adverse events (moderate): sinus tachycardia (1 brexanolone patient), somnolence (1 brexanolone patient), infusion site pain (1 placebo patient), tension headache (1 placebo patient)
  • Treatment-emergent adverse event (severe): insomnia (1 placebo patient)