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Randomized Controlled Trial
. 2023 Jan 1:320:353-359.
doi: 10.1016/j.jad.2022.09.143. Epub 2022 Sep 30.

Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program

C Neill Epperson  1 , David R Rubinow  2 , Samantha Meltzer-Brody  2 , Kristina M Deligiannidis  3 , Robert Riesenberg  4 , Andrew D Krystal  5 , Kemi Bankole  6 , Ming-Yi Huang  6 , Haihong Li  6 , Colville Brown  6 , Stephen J Kanes  6 , Robert Lasser  6
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Free article
Randomized Controlled Trial

Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program

C Neill Epperson et al. J Affect Disord. .
Free article

Abstract

Background: Brexanolone is currently the only treatment specifically approved for postpartum depression (PPD) in the United States, based on the results from one Phase 2 and two Phase 3 double-blind, randomized, controlled trials in the HUMMINGBIRD program.

Methods: Adults with PPD randomized to a 60-h infusion of brexanolone 90 μg/kg/h (BRX90) or placebo from the 3 trials were included in these post hoc analyses. Data on change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, HAMD-17 Anxiety/Somatization and Insomnia subscales, and Clinical Global Impression of Improvement (CGI-I) scale were pooled. Response rates for HAMD-17 (≥50 % reduction from baseline) and CGI-I (score of 1 or 2) scales and time to response were analyzed.

Results: Patients receiving BRX90 (n = 102) versus placebo (n = 107) achieved a more rapid HAMD-17 response (median, 24 vs 36 h; p = 0.0265), with an Hour-60 cumulative response rate of 81.4 % versus 67.3 %; results were similar for time to CGI-I response (median, 24 vs 36 h; p = 0.0058), with an Hour-60 cumulative response rate of 81.4 % versus 61.7 %. CFB in HAMD-17 Anxiety/Somatization and Insomnia subscales also favored BRX90 versus placebo, starting at Hour 24 through Day 30 (all p < 0.05), and response rates for both subscales were higher with BRX90.

Limitations: The study was not powered to assess exploratory outcomes.

Conclusions: Brexanolone was associated with rapid improvement in depressive symptoms and symptoms of anxiety and insomnia compared with placebo in women with PPD. These data continue to support the use of brexanolone to treat adults with PPD.

Keywords: Antidepressant; Anxiety; Brexanolone; Neuroactive steroid; Postpartum depression.

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Conflict of interest statement

Declaration of competing interest C. Neill Epperson serves on an advisory board for Asarina Pharma and Babyscripts; reports grants awarded to the University of Colorado from Sage Therapeutics, Inc. and HealthRhythms; and receives consulting fees/honoraria from Sage Therapeutics, Inc. David R. Rubinow serves as a consultant and a clinical advisory board co-chair for Sage Therapeutics, Inc.; receives consulting fees and travel/meeting support from Sage Therapeutics, Inc.; and reports grants awarded to University of North Carolina from Sage Therapeutics, Inc. Dr. Rubinow also holds stock options from Sage Therapeutics, Inc. Samantha Meltzer-Brody reports grants awarded to University of North Carolina from Sage Therapeutics, Inc. Dr. Meltzer-Brody also received honoraria from Sage Therapeutics, Inc. Kristina M. Deligiannidis serves as a consultant to Sage Therapeutics, Inc., Brii Biosciences, Inc., and GH Research Ireland Limited, and as a council/board member for Society of Biological Psychiatry and American Society of Clinical Psychopharmacology. Dr. Deligiannidis reports grants awarded to Zucker Hillside Hospital/Feinstein Institutes for Medical Research from Sage Therapeutics, Inc. during the conduct of the brexanolone injection and zuranolone clinical trials. Dr. Deligiannidis also received grants from NIH and Vorso Corporation, royalties from an NIH employee invention outside of the submitted work, payments/honoraria from Platform Q Health Education CME and Peer View Institute for Medical Education, and travel/meeting support from Sage Therapeutics, Inc. and Vorso Corporation. Robert Riesenberg has no conflict of interest to declare. Andrew D. Krystal participates on a data safety monitoring board/advisory board for Idorsia and Neurocrine Biosciences; receives payments/honoraria from Eisai and Idorsia and consulting fees from Adare, Axsome Therapeutics, Big Health, Eisai, Evecxia, Ferring Pharmaceuticals, Galderma, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Millenium Pharmaceuticals, Merck, Neurocrine Biosciences, Neurawell, Pernix, Otsuka Pharmaceuticals, Sage Therapeutics, Inc., Takeda, and Angelini; and reports grants from Janssen Pharmaceuticals, Axsome Pharmaceutics, Reveal Biosensors, The Ray and Dagmar Dolby Family Fund, and NIH. Dr. Krystal also holds stock options from Big Health. Kemi Bankole, Ming-Yi Huang, Colville Brown, and Robert Lasser are employees of Sage Therapeutics, Inc. and hold stock and/or stock options. Haihong Li and Stephen J. Kanes are former employees of Sage Therapeutics, Inc. and may hold stock and/or stock options. Dr. Kanes is also an inventor of the patent entitled “Neuroactive steroids, compositions, and uses thereof” (US10940156B2), which relates to methods of using brexanolone to treat certain diseases.

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