A 1-Year, Open-Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder
A 1-Year, Open-Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder
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DOI：
10.1097/jcp.0b013e31822c6741
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发表时间：
2011-10-01
影响因子：
2.9
通讯作者：
Reed, Carol R.
中科院分区：
文献类型：
--
作者：
Robinson, Donald S.;Kajdasz, Daniel K.;Reed, Carol R.
维拉唑酮是一种选择性5-羟色胺(5-HT)再摄取抑制剂和5-HT1a受体部分激动剂，在两项为期8周的成人抑郁症安慰剂对照研究中效果显著。这项开放标签的多中心研究评估了维拉唑酮的长期安全性。17项汉密尔顿抑郁量表评分在18或以上的成年患者，根据固定滴定方案接受维拉唑酮治疗，剂量达到40 mg/d，持续治疗1年。安全性评估包括不良事件(AEs)、体格检查、临床化学、心电图和性功能改变问卷。用蒙哥马利-阿斯伯格抑郁量表和临床总体印象量表评估疗效。安全人群包括599名患者；254名患者完成了一年的治疗。最常见的不良反应是腹泻(35.7%)、恶心(31.6%)和头痛(20.0%)，其中90%以上为轻度或中度不良反应。在超过1%的患者中，导致停药的不良事件是恶心(1.3%)和腹泻(1.2%)。在体格检查、心电图或临床化学方面没有临床上重要的变化。平均体重增加1.7公斤(观察病例)。性功能问卷的变化意味着在治疗过程中男性和女性的得分(观察病例)都有所改善。蒙哥马利-阿斯伯格抑郁量表在基线、第8周和第52周的平均得分分别为29.9、11.4和7.1(观察病例)。维拉唑酮40 mg/d，疗程1年是安全的，成人重度抑郁障碍患者耐受性良好。
Vilazodone, a selective serotonin (5-HT) reuptake inhibitor and 5-HT1A receptor partial agonist, was efficacious in two 8-week placebo-controlled studies in adults with major depressive disorder. This open-label, multicenter study assessed the long-term safety of vilazodone. Adult patients with a 17-item Hamilton Rating Scale for Depression score of 18 or greater received vilazodone according to a fixed-titration schedule to reach a dose of 40 mg/d continued up to 1 year. Safety assessments included adverse events (AEs), physical examinations, clinical chemistry, electrocardiograms, and the Changes in Sexual Functioning Questionnaire. Effectiveness was assessed with the Montgomery-Asberg Depression Rating Scale and Clinical Global Impressions scales. The safety population comprised 599 patients; 254 patients completed 1 year of treatment. The most frequent AEs were diarrhea (35.7%), nausea (31.6%), and headache (20.0%); greater than 90% of these AEs were mild or moderate. Adverse events resulting in discontinuation in more than 1% of patients were nausea (1.3%) and diarrhea (1.2%). There were no clinically important changes in physical examinations, electrocardiograms, or clinical chemistries. Mean weight increased by 1.7 kg (observed cases). Changes in Sexual Functioning Questionnaire mean scores (observed cases) improved throughout treatment for both males and females. Montgomery-Asberg Depression Rating Scale mean scores were 29.9 at baseline, 11.4 at week 8, and 7.1 at week 52 (observed cases). Vilazodone 40 mg/d for 1 year was safe and well tolerated by adults with major depressive disorder.