Deligiannidis Kristina M, Citrome Leslie, Huang Ming-Yi, Acaster Sarah, Fridman Moshe, Bonthapally Vijayveer, Lasser Robert, Kanes Stephen J
Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York.
Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York.
J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475.
Concurrent anxiety and/or insomnia symptoms in women with postpartum depression (PPD) are common and associated with more severe PPD. The effects of zuranolone on concurrent anxiety and/or insomnia symptoms and on patient-perceived functional health in women with PPD in the ROBIN study are reported. The phase 3, double-blind, randomized, placebo-controlled trial (conducted January 2017-December 2018) included women aged 18-45 years, ≤ 6 months postpartum, with PPD (onset of -defined major depressive episode in the third trimester or ≤ 4 weeks postpartum) and baseline 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 26. Women were randomized 1:1 to once-daily oral zuranolone 30 mg (n = 77) or placebo (n = 76) for 14 days with follow-up through day 45. Concurrent remission of depressive and anxiety symptoms (Hamilton Anxiety Rating Scale total score ≤ 7 plus HDRS-17 total score ≤ 7 or Montgomery-Asberg Depression Rating Scale total score ≤ 10), improvement in insomnia symptoms, patient-perceived functional health, and treatment effect sizes described by number needed to treat (NNT) were assessed. Analyses were exploratory; values are nominal. Rates of concurrent remission of depressive and anxiety symptoms were higher with zuranolone versus placebo < .05) at days 3, 15, and 45; the rate of sustained concurrent remission (ie, at both days 15 and 45) was also higher with zuranolone ( < .05). Anxiety symptoms (assessed by HDRS-17 anxiety/somatization subscale and Edinburgh Postnatal Depression Scale anxiety subscale) improved with zuranolone versus placebo ( < .05) at days 3 through 45. Potential benefits on insomnia symptoms and patient-perceived functional health were observed. Day 15 NNTs were 5 for both HDRS-17 response and remission. Zuranolone was associated with concurrent improvements in depressive and anxiety symptoms, with beneficial effects on insomnia symptoms and patient-perceived functional health in adults with PPD. ClinicalTrials.gov identifier: NCT02978326.
产后抑郁症（PPD）女性并发焦虑和/或失眠症状很常见，且与更严重的PPD相关。本文报告了ROBIN研究中zuranolone对PPD女性并发焦虑和/或失眠症状以及患者自我感知的功能健康的影响。这项3期、双盲、随机、安慰剂对照试验（于2017年1月至2018年12月进行）纳入了年龄在18 - 45岁、产后≤6个月、患有PPD（在孕晚期或产后≤4周出现定义的重度抑郁发作）且基线17项汉密尔顿抑郁量表（HDRS - 17）总分≥26的女性。女性被随机分为1:1两组，一组每日口服一次30 mg的zuranolone（n = 77），另一组口服安慰剂（n = 76），为期14天，并随访至第45天。评估了抑郁和焦虑症状的同时缓解情况（汉密尔顿焦虑量表总分≤7加上HDRS - 17总分≤7或蒙哥马利 - 阿斯伯格抑郁量表总分≤10）、失眠症状的改善情况、患者自我感知的功能健康以及用治疗所需人数（NNT）描述的治疗效应大小。分析为探索性的；数值为名义值。在第3天、第15天和第45天，与安慰剂相比，zuranolone组抑郁和焦虑症状同时缓解的比例更高（P < 0.05）；zuranolone组持续同时缓解（即第15天和第45天都缓解）的比例也更高（P < 0.05）。在第3天至第45天，与安慰剂相比，zuranolone组焦虑症状（通过HDRS - 17焦虑/躯体化子量表和爱丁堡产后抑郁量表焦虑子量表评估）有所改善（P < 0.05）。观察到对失眠症状和患者自我感知的功能健康有潜在益处。第15天，HDRS - 17有反应和缓解的NNT均为5。Zuranolone与抑郁和焦虑症状的同时改善相关，对患有PPD的成年人的失眠症状和患者自我感知的功能健康有有益影响。ClinicalTrials.gov标识符：NCT02978326。
