Abstract：
Several bipolar depression treatment guidelines have been designed to assist clinicians with medication selection. When ranking medications, none explicitly considered the inclusion/exclusion criteria or baseline severity scores of the reviewed clinical trials. This article aimed to determine if sufficient differences exist in these variables to justify their consideration when designing treatment guidelines.
Using Ovid and PubMed databases in May and September 2022, all published, short-term cross-over or parallel-group design studies comparing second generation antipsychotics (SGAs), mood stabilizers, or antidepressants versus placebo in bipolar depressed patients were identified. Included studies must have enrolled adult bipolar I/II depressed patients, randomized patients into two or more treatment groups, utilized a double-blind, prospective design written in English, and had primary outcome results that were statistically significant in favor of the investigational treatment.
Thirty studies met eligibility criteria, comprising a total of 8791 patients. Among those studies, there were seventeen antipsychotic trials, six lithium trials, one lamotrigine trial, three valproate trials, two carbamazepine trials, and two antidepressant trials. The analysis revealed substantial differences among the studies. Although this was seen among all the different drug classes, these differences are clearest when comparing the lithium trials to those of the SGAs.
Limitations included the selection of severity scores from the treatment arm with the most severe score and the exclusive focus on mood stabilizers, antidepressants, and SGAs.
Severity of the enrolled patient sample and treatment-resistance should be considered in addition to other factors when ranking medications in bipolar depression treatment guidelines.
Using Ovid and PubMed databases in May and September 2022, all published, short-term cross-over or parallel-group design studies comparing second generation antipsychotics (SGAs), mood stabilizers, or antidepressants versus placebo in bipolar depressed patients were identified. Included studies must have enrolled adult bipolar I/II depressed patients, randomized patients into two or more treatment groups, utilized a double-blind, prospective design written in English, and had primary outcome results that were statistically significant in favor of the investigational treatment.
Thirty studies met eligibility criteria, comprising a total of 8791 patients. Among those studies, there were seventeen antipsychotic trials, six lithium trials, one lamotrigine trial, three valproate trials, two carbamazepine trials, and two antidepressant trials. The analysis revealed substantial differences among the studies. Although this was seen among all the different drug classes, these differences are clearest when comparing the lithium trials to those of the SGAs.
Limitations included the selection of severity scores from the treatment arm with the most severe score and the exclusive focus on mood stabilizers, antidepressants, and SGAs.
Severity of the enrolled patient sample and treatment-resistance should be considered in addition to other factors when ranking medications in bipolar depression treatment guidelines.
摘要：
背景：已经设计了一些双相抑郁治疗指南来帮助临床医生选择药物。在对药物进行排名时，没有明确考虑纳入/排除标准或基线严重程度评分的临床试验.本文旨在确定这些变量是否存在足够的差异，以证明在设计治疗指南时需要考虑。
方法：在2022年5月和9月使用Ovid和PubMed数据库，全部发布，比较第二代抗精神病药（SGAs）的短期交叉或平行组设计研究，情绪稳定剂，或抗抑郁药与安慰剂在双相抑郁患者中的差异被确定。纳入的研究必须招募成人双相I/II抑郁症患者，将患者随机分为两个或多个治疗组，利用双盲，用英语写的前瞻性设计，并且主要结局结果具有统计学显著性,有利于研究性治疗.
结果：30项研究符合资格标准，共有8791名患者。在这些研究中,有17项抗精神病药物试验，六次锂试验，一项拉莫三嗪试验,三项丙戊酸盐试验，两项卡马西平试验,和两项抗抑郁试验。分析揭示了研究之间的实质性差异。尽管这在所有不同的药物类别中都可以看到，当将锂试验与SGA的试验进行比较时，这些差异是最明显的。
结论：限制包括从最严重评分的治疗组中选择严重程度评分，并且仅关注情绪稳定剂，抗抑郁药,和SGA。
结论：在双相抑郁治疗指南中对药物进行排名时，除了其他因素外，还应考虑入选患者样本的严重程度和治疗抵抗。
方法：在2022年5月和9月使用Ovid和PubMed数据库，全部发布，比较第二代抗精神病药（SGAs）的短期交叉或平行组设计研究，情绪稳定剂，或抗抑郁药与安慰剂在双相抑郁患者中的差异被确定。纳入的研究必须招募成人双相I/II抑郁症患者，将患者随机分为两个或多个治疗组，利用双盲，用英语写的前瞻性设计，并且主要结局结果具有统计学显著性,有利于研究性治疗.
结果：30项研究符合资格标准，共有8791名患者。在这些研究中,有17项抗精神病药物试验，六次锂试验，一项拉莫三嗪试验,三项丙戊酸盐试验，两项卡马西平试验,和两项抗抑郁试验。分析揭示了研究之间的实质性差异。尽管这在所有不同的药物类别中都可以看到，当将锂试验与SGA的试验进行比较时，这些差异是最明显的。
结论：限制包括从最严重评分的治疗组中选择严重程度评分，并且仅关注情绪稳定剂，抗抑郁药,和SGA。
结论：在双相抑郁治疗指南中对药物进行排名时，除了其他因素外，还应考虑入选患者样本的严重程度和治疗抵抗。
