CLINICAL TRIAL, PHASE III
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Zuranolone for the Treatment of Postpartum Depression.

OBJECTIVE: Postpartum depression (PPD) is a common perinatal complication with adverse maternal and infant outcomes. This study investigated the efficacy and safety of zuranolone, a positive allosteric modulator of synaptic and extrasynaptic GABAA receptors and neuroactive steroid, as an oral, once-daily, 14-day treatment course for patients with severe PPD.

METHODS: In this double-blind phase 3 trial, women with severe PPD were randomized in a 1:1 ratio to receive zuranolone 50 mg/day or placebo for 14 days. The primary endpoint was change from baseline in total score on the 17-item Hamilton Depression Rating Scale (HAM-D) at day 15; key secondary endpoints were change from baseline in HAM-D score at days 3, 28, and 45 and change from baseline in Clinical Global Impressions severity (CGI-S) score at day 15. Adverse events were monitored.

RESULTS: Among 196 patients randomized (zuranolone, N=98; placebo, N=98), 170 (86.7%) completed the 45-day study. Treatment with zuranolone compared with placebo resulted in statistically significant improvement in depressive symptoms at day 15 (least squares mean [LSM] change from baseline in HAM-D score, -15.6 vs. -11.6; LSM difference, -4.0, 95% CI=-6.3, -1.7); significant improvement in depressive symptoms was also reported at days 3, 28, and 45. CGI-S score at day 15 significantly improved with zuranolone compared with placebo. The most common adverse events (≥10%) with zuranolone were somnolence, dizziness, and sedation. No loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior were observed.

CONCLUSIONS: In this trial, zuranolone demonstrated significant improvements in depressive symptoms and was generally well tolerated, supporting the potential of zuranolone as a novel, rapid-acting oral treatment for PPD.

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Ep13 - Breaking New Ground: Zuranolone's Potential for Postpartum Depression

Join us for the next episode of the Psychiatry Update Journal Club as we explore a major breakthrough in the field of postpartum depression (PPD) treatment. Dr. Leslie Citrome will be in conversation with Dr. Kristina Deligiannidis, lead author of a journal article describing a remarkable double-blind phase 3 trial assessing the potential of zuranolone as an oral treatment for severe PPD.

Save the date for this session on Monday, October 16, 2023 @ 10:00 AM EST. Register now via the button below.

Postpartum depression is a significant perinatal complication with far-reaching consequences for both mothers and infants.

This phase 3 trial assesses the potential of zuranolone as a new option for PPD treatment. Zuranolone is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors with an oral, once daily, 14-day treatment course. Zuranolone demonstrated rapid, sustained and clinically meaningful results. Significant benefits were seen as early as day 3!

Our discussion will encompass a review of the study as well as touching on current screening and treatment practices for PPD, and the possible future implications of this study for the management of PPD. Don't miss this opportunity to be part of the conversation that could redefine how we approach PPD care.

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