| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double-blind, randomized, placebo-controlled, Phase 3 clinical trial |
| 掲載誌名 | 正式名：Psychiatry and clinical neurosciences 略 称：Psychiatry Clin Neurosci ISSNコード：14401819/13231316 |
| 掲載区分 | 国外 |
| 巻・号・頁 | pp.Online ahead of print |
| 著者・共著者 | Masaki Kato, Kazuyuki Nakagome, Takamichi Baba, Takuhiro Sonoyama, Hiroki Fukuju, Ryosuke Shimizu, Juan Carlos Gomez, Tomoko Motomiya, Takeshi Inoue |
| 発行年月 | 2025/11 |
| 概要 | AIM:To evaluate the efficacy and safety of oral zuranolone for 14 days, compared with placebo, in Japanese patients with major depressive disorder (MDD).METHODS:This multicenter, Phase 3 study was conducted in two parts (70 sites; Japan) including a randomized, double-blind, placebo-controlled, parallel-group part presented herein. Participants aged 18-75 years with the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score ≥ 22 were randomized (1:1) ratio to receive either zuranolone (30 mg once daily) or placebo for 14 days with follow-up on Days 3, 8, and 15 and then weekly for 6 weeks (57 days) thereafter. The primary endpoint was change from baseline in the HAMD-17 total score at Day 15.RESULTS:Overall, 412 participants were randomized to receive either zuranolone 30 mg (n = 207) or placebo (n = 205). The difference in the least-squares mean (95% confidence interval [CI]) change from baseline in the HAMD-17 total score between groups (-1.20; 95% CI: -2.32, -0.08; P = 0.0365) was statistically significant on Day 15. A significant improvement in the HAMD-17 total score was observed with zuranolone 30 mg during the early treatment period on Days 3 and 8 compared with placebo; however, no significant differences were observed between the groups at later time points, from Day 22 to Day 57. The frequency of adverse events was higher in the zuranolone group (55.1%) than in the placebo group (40.7%); however, no serious adverse events were reported.CONCLUSION:Zuranolone improved depressive symptoms on Day 15, compared with placebo, in Japanese patients with MDD. No new safety signals were observed.CLINICAL TRIAL REGISTRATION:jRCT2031210577. |
| DOI | 10.1111/pcn.13917 |
| PMID | 41251319 |