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

The Lancet Jun 28, 2017

Kanes S, et al. – Efficacy of brexanolone for the treatment of post–partum depression was assessed in this current study and it was found that brexanolone infusion versus placebo administration resulted in a significant and clinically meaningful reduction in Hamilton Rating Scale for Depression [HAM-D] total score in women with severe post–partum depression.

Methods

  • Researchers performed this double-blind, randomised, placebo-controlled trial enrolling self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA.
  • They used a computer-generated randomisation program to randomly assign (1:1) eligible women to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h.
  • Patients and investigators were masked to treatment assignments.
  • The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment.
  • They followed patients until day 30.

Results

  • As per data, this trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient).
  • In this study, 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups.
  • Findings reported that at 60 h, mean reduction in HAM-D total score from baseline was 21·0 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).
  • Results did not highlight deaths, serious adverse events, or discontinuations because of adverse events in either group.
  • It was found that four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group.
  • Researchers noted that the most frequently reported adverse events in the brexanolone group were dizziness (two patients in the brexanolone group vs three patients in the placebo group) and somnolence (two vs none).
  • As per outcomes, moderate treatment-emergent adverse events were reported in two patients in the brexanolone group (sinus tachycardia, n=1; somnolence, n=1) and in two patients in the placebo group (infusion site pain, n=1; tension headache, n=1); one patient in the placebo group had a severe treatment-emergent adverse event (insomnia).

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