Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.
Department of Psychiatry, National Center of Neurology and Psychiatry, Tokyo, Japan.
Psychiatry Clin Neurosci. 2023 Sep;77(9):497-509. doi: 10.1111/pcn.13569. Epub 2023 Jun 21.
To evaluate the efficacy and safety of an oral, once-daily, 14-day treatment course of zuranolone in Japanese patients with major depressive disorder (MDD).
This multicenter, randomized, double-blind, placebo-controlled study randomized eligible patients (1:1:1) to receive oral zuranolone 20 mg, zuranolone 30 mg, or placebo once daily for 14 days (treatment-period), followed by two 6-week follow-up periods. The primary endpoint was change from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score on Day 15.
Overall, 250 patients (enrolled: 07/07/2020-05/26/2021) were randomized to receive placebo (n = 83), zuranolone 20 mg (n = 85), or zuranolone 30 mg (n = 82). The demographic and baseline characteristics were balanced between groups. The adjusted mean (standard error) change from baseline in the HAMD-17 total score on Day 15 was -6.22 (0.62), -8.14 (0.62), and - 8.31 (0.63) in the placebo, zuranolone 20-mg, and zuranolone 30-mg groups, respectively. Significant differences in the adjusted mean (95% confidence interval [CI]) for zuranolone 20 mg versus placebo (-1.92; [-3.65, -0.19]; P = 0.0296) and zuranolone 30 mg versus placebo (-2.09; [-3.83, -0.35]; P = 0.0190) groups were observed on Day 15, and also as early as Day 3. A nonsignificant yet distinct drug-placebo separation was observed during follow-up. Somnolence (placebo [3.7%], zuranolone 20 mg [10.6%], and zuranolone 30 mg [20.7%]) and dizziness (3.7%, 9.4%, and 9.8%, respectively) were more common with zuranolone.
Oral zuranolone was safe and demonstrated significant improvements in depressive symptoms, as assessed by HAMD-17 total score change from baseline over 14 days in Japanese patients with MDD.
评估口服、每日 1 次、14 天疗程的 zuranolone 在日本重度抑郁症（MDD）患者中的疗效和安全性。
这是一项多中心、随机、双盲、安慰剂对照研究，将符合条件的患者（1:1:1）随机分配接受口服 zuranolone 20mg、zuranolone 30mg 或安慰剂，每日 1 次，共 14 天（治疗期），随后进行两个 6 周的随访期。主要终点是第 15 天基线时 17 项汉密尔顿抑郁量表（HAMD-17）总分的变化。
共有 250 名患者（入组时间：2020 年 7 月 7 日至 2021 年 5 月 26 日）被随机分配接受安慰剂（n=83）、zuranolone 20mg（n=85）或 zuranolone 30mg（n=82）。各组之间的人口统计学和基线特征平衡。第 15 天 HAMD-17 总分的调整平均（标准误差）变化分别为安慰剂组-6.22（0.62）、zuranolone 20mg 组-8.14（0.62）和 zuranolone 30mg 组-8.31（0.63）。与安慰剂相比，zuranolone 20mg 组（-1.92；[-3.65，-0.19]；P=0.0296）和 zuranolone 30mg 组（-2.09；[-3.83，-0.35]；P=0.0190）的调整均值（95%置信区间[CI]）差异有统计学意义，并且在第 3 天也观察到了明显的药物-安慰剂分离。在随访期间观察到嗜睡（安慰剂[3.7%]、zuranolone 20mg[10.6%]和 zuranolone 30mg[20.7%]）和头晕（3.7%、9.4%和 9.8%）更为常见。
口服 zuranolone 在日本 MDD 患者中，在 14 天内通过 HAMD-17 总分从基线的变化评估，显示出安全且显著的抑郁症状改善。
