Thase Michael E, Edwards John, Durgam Suresh, Chen Changzheng, Chang Cheng-Tao, Mathews Maju, Gommoll Carl P
aDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania bAllergan, Jersey City cAllergan, Bridgewater dForest Research Institute, an Allergan affiliate, Jersey City, New Jersey, USA.
Int Clin Psychopharmacol. 2017 Sep;32(5):281-288. doi: 10.1097/YIC.0000000000000180.
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.
治疗引发的自杀观念和行为一直是抗抑郁药物令人担忧的问题。维拉唑酮目前已被批准用于治疗成人重度抑郁症（MDD），也已在广泛性焦虑症（GAD）中进行了评估。对维拉唑酮试验进行了事后分析，以研究其对患有MDD或GAD的成年人自杀观念和行为的影响。数据来自维拉唑酮治疗MDD的试验（四项研究）和GAD的试验（三项研究）。基于治疗引发的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。基于C-SSRS分类从基线时无自杀观念/行为（C-SSRS=0）转变为治疗期间出现自杀观念（C-SSRS=1-5），对治疗引发的自杀观念进行了分析。在汇总的安全人群中（MDD，n=2233；GAD，n=1475），接受维拉唑酮治疗和接受安慰剂治疗的患者中，与自杀相关的治疗引发不良事件发生率均低于1%。C-SSRS自杀观念的发生率如下：MDD（维拉唑酮=19.9%，安慰剂=24.7%）；GAD（维拉唑酮=7.7%，安慰剂=9.4%）。从基线时无自杀观念/行为转变为治疗期间出现自杀观念的比例如下：MDD（维拉唑酮=9.4%，安慰剂=10.3%）；GAD（维拉唑酮=4.4%，安慰剂=6.1%）。来自安慰剂对照研究的数据表明，维拉唑酮治疗患有MDD或GAD的成年人时，出现治疗引发的自杀观念或行为的风险很小或没有。然而，所有患者在抗抑郁治疗期间都应监测自杀想法和行为。
