A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

Summary

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

Timeline

Start

2016-08-01

Primary completion

2017-09-24

Completion

2017-10-19

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs SAGE-547 60 μg/kg/h; p = 0.0013; Least Square (LS) Mean Difference -5.50 (95% CI -8.80 to -2.20); MMRM NCT02942004 ↗

registry analysis (superiority test); Placebo vs SAGE-547 90 μg/kg/h; p = 0.0252; LS mean difference -3.68 (95% CI -6.90 to -0.47); MMRM NCT02942004 ↗

Publications

• Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.
• Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexanolone	Unknown	60 ug/kg	Intravenous
Subject	Brexanolone	Unknown	90 ug/kg	Intravenous

Indications