Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States.
J Affect Disord. 2020 Oct 1;275:44-47. doi: 10.1016/j.jad.2020.06.021. Epub 2020 Jun 26.
This report seeks to evaluate improvements in symptoms of irritability with sertraline (a selective serotonin reuptake inhibitor antidepressant) versus placebo.
Participants of Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study who were randomized to 8 weeks of treatment with either sertraline or placebo and completed 5-item irritability domain of Concise Associated Symptom Tracking scale (CAST-IRR) at baseline were included (n = 292). Repeated measures mixed model analysis with CAST-IRR as the outcome variable and treatment arm-by-time interaction as the independent variable of interest evaluated whether changes in irritability with treatment differed between sertraline and placebo arms. A separate analysis controlled for levels of overall depression severity (17-item Hamilton Depression Rating Scale). Covariates included age, sex, race, ethnicity, and site.
There was a significant treatment arm-by-time interaction (F = 6.96, df = 6, 1418, p <0.0001) suggesting that changes in irritability with sertraline differed from placebo. The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56). After controlling for levels of overall depression severity at each visit, reduction in irritability with time continued to be significant with sertraline but not with placebo.
Secondary analysis, limited generalizability, lack of non-serotonergic antidepressants.
There is greater improvement in irritability with sertraline than with placebo. Improvement in irritability with sertraline was independent of its effects on overall depression severity. CLINICALTRIALS.
NCT01407094.
本报告旨在评估舍曲林（一种选择性 5-羟色胺再摄取抑制剂抗抑郁药）与安慰剂相比改善易激惹症状的效果。
纳入参加建立临床护理中抗抑郁反应的调节因子和生物标志物（EMBARC）研究的患者，他们被随机分配到接受 8 周舍曲林或安慰剂治疗，并在基线时完成简明相关症状跟踪量表（CAST-IRR）的 5 项易激惹域。使用 CAST-IRR 作为因变量，治疗臂-时间交互作用作为感兴趣的自变量，采用重复测量混合模型分析评估治疗组之间易激惹症状的变化是否存在差异。单独的分析控制了整体抑郁严重程度（17 项汉密尔顿抑郁评定量表）的水平。协变量包括年龄、性别、种族、民族和地点。
治疗臂-时间交互作用显著（F=6.96，df=6，1418，p<0.0001），提示舍曲林治疗后易激惹的变化与安慰剂不同。与安慰剂相比，舍曲林治疗后易激惹的缓解程度更大（Cohen's d 效应大小=0.56）。在每次就诊时控制整体抑郁严重程度的水平后，随着时间的推移，易激惹的缓解在舍曲林组中仍然显著，但在安慰剂组中则不显著。
二次分析，有限的通用性，缺乏非 5-羟色胺能抗抑郁药。
舍曲林改善易激惹的效果优于安慰剂。舍曲林改善易激惹的效果独立于其对整体抑郁严重程度的影响。临床试验。
gov 标识符：NCT01407094。
