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Reply to Bisol: Critical review and recommendations for enhancement of the article on novel neurosteroid therapeutics for postpartum depression

Neuropsychopharmacology (2024)Cite this article

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The U.S. Food and Drug Administration (FDA) approved brexanolone for the treatment of moderate-to-severe postpartum depression (PPD) in March of 2019. Our aim was not to critically review the methodology of the clinical trials or the FDA approval of brexanolone, but instead to provide context for these developments and to comment on the neurosteroid therapeutic landscape as it evolves.

Many of Bisol et al. comments are directed at The Lancet phase 3 clinical trial manuscript published in 2018, rather than being specific to our review paper. We are perplexed by their comments, which contain many inaccurate statements, and we have tried to clarify here.

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References

  1. Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, et al. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet 2018;392:1058–70.

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Acknowledgements

SM-B has previously received research funding as an Investigator to UNC from Sage Therapeutics for other projects. SM-B has received consulting fees from EmbarckNeuro, Modern Health, Neuroscience Education Institute and Web MD. Past work reflected here was partially funded by a grant from the Foundation of Hope, Raleigh, NC and support from the UNC School of Medicine, Chapel Hill, NC.

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Authors and Affiliations

  1. Departments of Psychiatry and Emergency Medicine, UNC Center for Women’s Mood Disorders, Chapel Hill, NC, USA

    Riah Patterson

  2. Department of Psychiatry, UNC Center for Women’s Mood Disorders, Chapel Hill, NC, USA

    Samantha Meltzer-Brody

Authors
  1. Riah Patterson
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  2. Samantha Meltzer-Brody
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Contributions

Riah Patterson: drafting the work, and substantial contributions to the conception or design of the work; the acquisition, analysis, and interpretation of data for the work. Samantha Meltzer-Brody: drafting the work or revising it critically for important intellectual content and final approval of the version to be published. Both authors agree to be accountable for all aspects of the work.

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Correspondence to Riah Patterson.

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Competing interests

The authors declare no potential conflicts of interest. Per above, SM-B has served as the academic PI for the brexanolone clinical trials and received research funding to UNC for these studies.

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Patterson, R., Meltzer-Brody, S. Reply to Bisol: Critical review and recommendations for enhancement of the article on novel neurosteroid therapeutics for postpartum depression. Neuropsychopharmacol. (2024). https://doi.org/10.1038/s41386-024-01818-1

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