Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial.

ABSTRACT:

Importance

Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy, negatively affecting both mother and child.

Objective

To demonstrate the efficacy and safety of zuranolone, a neuroactive steroid γ-aminobutyric acid receptor-positive allosteric modulator, in PPD.

Design, setting, and participants

This phase 3, double-blind, randomized, outpatient, placebo-controlled clinical trial was conducted between January 2017 and December 2018 in 27 enrolling US sites. Participant were women aged 18 to 45 years, 6 months or fewer post partum, with PPD (major depressive episode beginning third trimester or ≤4 weeks postdelivery), and baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score of 26 or higher. Analysis was

SUBMITTER: Deligiannidis KM 

PROVIDER: S-EPMC8246337 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature