A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder
A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder
复制标题
DOI：
10.4088/jcp.v64n0216
复制
发表时间：
2003-02-01
影响因子：
5.3
通讯作者：
Amsterdam, JD
中科院分区：
文献类型：
--
作者：
Amsterdam, JD
背景：单胺氧化酶（MAO）抑制剂司来吉兰的抗抑郁疗效上级于安慰剂。已经开发了具有独特的药代动力学和药效学性质的司来吉兰透皮系统（STS），其允许抑制中枢神经系统MAO-A和MAO-B酶，同时基本上避免抑制肠和肝MAO-A酶。这种新的透皮系统提供了有针对性的MAO抑制作用，而对膳食酪胺的敏感性没有临床显著增加。我们调查了STS的安全性和有效性，在患者与major depression disorder.Method：365例门诊患者18至65岁的DSM-IV诊断的重性抑郁症在16个网站。要求17项汉密尔顿抑郁评定量表（HAM-D-17）评分大于或等于20分。患者被随机分配接受STS，20 mg/ 20 cm（2），每日或安慰剂贴剂，持续8周。既不需要也不建议限制酪胺饮食。疗效，安全性和生命体征的措施，定期获得。结果：289例患者被随机分配到治疗，并接受至少1个治疗中的评价（STS，N = 145;安慰剂，N = 144）。尽管效应量适中，但在终点时，STS在MADRS（p = .001）和HAM-D-28（p = .039）评级方面在统计学上上级优于安慰剂，在HAM-D-17（p = .069）和临床总体印象-严重程度评级（p < .055）方面显示出非显著性优效性。STS和安慰剂的副作用特征相似，除了在31.5%的STS患者和15.1%的安慰剂治疗患者中观察到的应用部位反应（p = .001）。没有显着差异，观察到血压的措施治疗groups.Conclusion：结果从这个双盲，安慰剂对照的临床试验表明，STS可能有一个温和的，但统计学上显着的，抗抑郁的好处相比，安慰剂和类似的安全性与安慰剂相比，在没有酪胺限制饮食。
Background: The monoamine oxidase (MAO) inhibitor selegiline has demonstrated antidepressant efficacy superior to placebo. A selegiline transdermal system (STS) has been developed with unique pharmacokinetic and pharmacodynamic properties that allow inhibition of central nervous system MAO-A and MAO-B enzymes while substantially avoiding inhibition of intestinal and liver MAO-A enzyme. This novel transdermal system provides targeted MAO inhibition without clinically significant increases in sensitivity to dietary tyramine. We investigated the safety and efficacy of STS in patients with major depressive disorder.Method: 365 outpatients 18 to 65 years old with a DSM-IV diagnosis of major depressive disorder were enrolled at 16 sites. A 17-item Hamilton Rating Scale for Depression (HAM-D-17) score of greater than or equal to 20 was required for entry. Patients were randomly assigned to receive either STS, 20 mg/ 20 cm(2), daily or placebo patch for up to 8 weeks. A tyramine-restricted diet was neither required nor advised. Efficacy, safety, and vital sign measures were obtained regularly.Results: 289 patients were randomly assigned to treatment and received at least 1 on-therapy evaluation (STS, N = 145; placebo, N = 144). Although the effect size was modest, at endpoint, STS was statistically superior to placebo on the MADRS (p = .001) and HAM-D-28 (p = .039) ratings and showed a nonsignificant superiority on the HAM-D-17 (p = .069) and Clinical Global Impressions-Severity ratings (p < .055). Side effect profiles were similar for STS and placebo with the exception of application-site reaction, which was observed in 31.5% of STS patients and 15.1% of placebo-treated patients (p = .001). No significant differences were observed in blood pressure measures between treatment groups.Conclusion: Results from this double-blind, placebo-controlled clinical trial demonstrate that STS may have a modest, but statistically significant, antidepressant benefit compared with placebo and a similar safety profile compared with placebo in the absence of a tyramine-restricted diet.