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Poster
1593993
Improvements in Depressive Symptoms in Patients With Major Depressive Disorder: Analysis of Zuranolone Efficacy From 4 Randomized, Placebo-Controlled Trials
Psych Congress 2023
The individual studies herein were sponsored by Sage Therapeutics, Inc. (201B, MOUNTAIN); Sage Therapeutics, Inc., and Biogen Inc (WATERFALL); or Shionogi & Co., Ltd. (1818A3731).
Zuranolone is an investigational positive allosteric modulator of synaptic and extrasynaptic GABAA receptors and neuroactive steroid in clinical development as an oral, once-daily, 14-day treatment course for adults with major depressive disorder (MDD) and postpartum depression. This analysis of 4 randomized, placebo-controlled trials assessed the efficacy of zuranolone in adults with MDD.
Patients received 30-mg zuranolone or placebo in 201B (NCT03000530), MOUNTAIN (NCT03672175; 20-mg data not reported), and 1818A3731 (JapicCTI-205276; 20-mg data not reported), and 50-mg zuranolone or placebo in WATERFALL (NCT04442490). Change-from-baseline (CFB) in 17-item Hamilton Depression Rating Scale total score (HAMD-17) and Cohen’s d were assessed at Day (D)3, D8, and D15, including Kaplan-Meier estimates of median time-to-HAMD-17 response (≥50% reduction from baseline).
CFB HAMD-17 significantly improved at D3, D8, and D15 in 30-mg (n=293) and 50-mg (n=265; nominal p
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