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首页> 美国卫生研究院文献>Lippincott Williams Wilkins Open Access >Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder: post-hoc analysis of randomized double-blind placebo-controlled trials
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Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder: post-hoc analysis of randomized double-blind placebo-controlled trials

机译：维拉唑酮对患有重度抑郁症或广泛性焦虑症的成年人的自杀意念和行为的影响：随机双盲安慰剂对照试验的事后分析

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Treatment-emergent suicidal ideation and behavior are ongoing concerns with antidepressants. Vilazodone, currently approved for the treatment of major depressive disorder (MDD) in adults, has also been evaluated in generalized anxiety disorder (GAD). Post-hoc analyses of vilazodone trials were carried out to examine its effects on suicidal ideation and behavior in adults with MDD or GAD. Data were pooled from vilazodone trials in MDD (four studies) and GAD (three studies). The incidence of suicide-related events was analyzed on the basis of treatment-emergent adverse event reporting and Columbia-Suicide Severity Rating Scale (C-SSRS) monitoring. Treatment-emergent suicidal ideation was analyzed on the basis of a C-SSRS category shift from no suicidal ideation/behavior (C-SSRS=0) at baseline to suicide ideation (C-SSRS=1–5) during treatment. In pooled safety populations (MDD, n=2233; GAD, n=1475), suicide-related treatment-emergent adverse events occurred in less than 1% of vilazodone-treated and placebo-treated patients. Incidences of C-SSRS suicidal ideation were as follows: MDD (vilazodone=19.9%, placebo=24.7%); GAD (vilazodone=7.7%, placebo=9.4%). Shifts from no suicidal ideation/behavior at baseline to suicidal ideation during treatment were as follows: MDD (vilazodone=9.4%, placebo=10.3%); GAD (vilazodone=4.4%, placebo=6.1%). Data from placebo-controlled studies indicate little or no risk of treatment-emergent suicidal ideation or behavior with vilazodone in adults with MDD or GAD. Nevertheless, all patients should be monitored for suicidal thoughts and behaviors during antidepressant treatment.
机译：产生治疗自杀意念和行为一直是抗抑郁药关注的问题。目前已批准用于治疗成人严重抑郁症（MDD）的Vilazodone，已被评估为广泛性焦虑症（GAD）。对维拉唑酮试验进行了事后分析，以检查其对患有MDD或GAD的成年人自杀意念和行为的影响。数据来自MDD（四项研究）和GAD（三项研究）的维拉唑酮试验。基于治疗紧急不良事件报告和哥伦比亚-自杀严重程度评定量表（C-SSRS）监测，分析了自杀相关事件的发生率。根据C-SSRS类别从治疗时的自杀意念/行为（C-SSRS = 0）转变为基线时的自杀意念（C-SSRS = 1–5），分析了发生治疗时的自杀意念。在合并的安全人群（MDD，n = 2233； GAD，n = 1475）中，与自杀相关的治疗紧急事件发生在不到1％接受维拉唑酮治疗和安慰剂治疗的患者中。 C-SSRS自杀意念的发生率如下：MDD（维拉唑酮= 19.9％，安慰剂= 24.7％）； GAD（维拉唑酮= 7.7％，安慰剂= 9.4％）。从基线无自杀意念/行为向治疗过程中自杀意念的转变如下：MDD（维拉唑酮= 9.4％，安慰剂= 10.3％）； GAD（维拉唑酮= 4.4％，安慰剂= 6.1％）。安慰剂对照研究的数据表明，在患有MDD或GAD的成人中，使用维拉唑酮治疗时产生自杀意念或行为的风险很小或没有风险。尽管如此，在抗抑郁治疗期间应监测所有患者的自杀念头和行为。

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