Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery The AFFINITY Randomized Clinical Trial
Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery The AFFINITY Randomized Clinical Trial
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DOI：
10.1001/jamaneurol.2021.2418
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发表时间：
2021-08-02
期刊：
影响因子：
29
通讯作者：
Hackett, Maree
中科院分区：
文献类型：
--
作者：
Almeida, Osvaldo P.;Hankey, Graeme J.;Hackett, Maree
重要性三分之一的成年人在中风后的第一年内经历临床显著的抑郁症状，但支持在这一人群中使用抗抑郁药的证据仍然很少。与参与者在卒中恢复中氟西汀评估的次要分析中，平行组，随机（1：1分配），双盲，安慰剂对照临床试验，在2013年1月11日至2019年6月30日期间招募了1221名澳大利亚，新西兰和越南的参与者，并随访6个月。年龄在18岁或以上的成年人在经历了与改良兰金量表评分为1或更高的卒中相关的2至15天后招募。干预措施盐酸氟西汀，20 mg，或匹配的安慰剂，每天26 whees.Main结局和测量9项患者健康问卷（PHQ-9）评分为9或更低是预先规定的次要结局。在基线和第4、12和26周完成评估。其他关注的结果包括参与者报告的抑郁症的临床诊断，非试验性抗抑郁药的处方，或抑郁症的非药物治疗。在意向治疗的基础上进行分析。（378名男性[62.3%];平均[SD]年龄，64.3 [12.2]岁）被随机分配安慰剂治疗，614名参与者（397名男性[64.7%];平均[SD]年龄，63.4 [12.4]岁）被随机分配接受每日20 mg盐酸氟西汀治疗。各组在人口统计学和临床指标方面保持平衡。基线时，安慰剂组112例患者（18.5%）和氟西汀组116例患者（18.9%）的PHQ-9评分≥ 9。在随访期间，596名接受安慰剂治疗的参与者中有126名（21.1%）和598名接受氟西汀治疗的参与者中有121名（20.2%）的PHQ-9评分为9或更高（P =.70）。在接受盐酸氟西汀和安慰剂治疗的基线时PHQ-9评分小于9的受试者中，有相似比例的受试者在试验期间PHQ-9评分为9或更高（安慰剂组，488人中有72人[14.8%];氟西汀组，485人中有63人[13.0%]; P = 0.43）。安慰剂组中有参与者报告的临床诊断为抑郁症的人数略高于氟西汀组（42/602 [7.0%] vs 26/601 [4.3%]; P = 0.05）。到第26周，14名参与者（2.3%）在安慰剂组和12名参与者氟西汀组死亡1.9%（P =.67）。结论和相关性用20 mg氟西汀进行日常治疗并没有降低中风后受临床显著抑郁症状影响的人的比例，与安慰剂相比，它也没有影响开抗抑郁药或接受非药物治疗的人的比例。
IMPORTANCE One in 3 adults experiences clinically significant symptoms of depression during the first year after a stroke, but evidence to support the use of antidepressants in this population remains scant.OBJECTIVE To investigate whether daily treatment with 20 mg of fluoxetine hydrochloride reduces the proportion of people affected by clinically significant symptoms of depression after stroke.DESIGN, SETTING, AND PARTICIPANTS In this secondary analysis of the Assessment of Fluoxetine in Stroke Recovery parallel-group, randomized (1:1 assignment), double-blind, placebo-controlled clinical trial, 1221 participants in Australia, New Zealand, and Vietnam were recruited between January 11, 2013, and June 30, 2019, and were followed up for 6 months. Adults aged 18 years or older were recruited 2 to 15 days after experiencing a stroke associated with modified Rankin Scale score of 1 or higher.INTERVENTIONS Fluoxetine hydrochloride, 20 mg, or matched placebo daily for 26 weeks.MAIN OUTCOMES AND MEASURES A 9-item Patient Health Questionnaire (PHQ-9) score of 9 or lower was a prespecified secondary outcome of the trial. Assessments were completed at baseline and at 4, 12, and 26 weeks. Other outcomes of interest included participant-reported clinician diagnosis of depression, prescription of a nontrial antidepressant, or nonpharmacologic treatment of depression. Analysis was on an intention-to-treat basis.RESULTS A total of 607 participants (378 men [62.3%]; mean [SD] age, 64.3 [12.2] years) were randomly assigned treatment with placebo, and 614 participants (397 men [64.7%]; mean [SD] age, 63.4 [12.4] years) were randomly assigned treatment with 20 mg of fluoxetine hydrochloride daily. The groups were balanced for demographic and clinical measures. At baseline, 112 patients (18.5%) in the placebo group and 116 patients (18.9%) in the fluoxetine group had PHQ-9 scores of 9 or higher. During follow-up, 126 of 596 participants (21.1%) treated with placebo and 121 of 598 participants (20.2%) treated with fluoxetine had PHQ-9 scores of 9 or higher (P = .70). A similar proportion of participants with PHQ-9 scores less than 9 at baseline who were treated with fluoxetine hydrochloride and placebo developed PHQ-9 scores of 9 or higher during the trial (placebo, 72 of 488 [14.8%]; and fluoxetine, 63 of 485 [13.0%]; P = .43). A slightly higher number of participants in the placebo group than in the fluoxetine group had a participant-reported clinician diagnosis of depression (42 of 602 [7.0%] vs 26 of 601 [4.3%]; P = .05). By week 26, 14 participants (2.3%) in the placebo group and 12 participants (1.9%) in the fluoxetine group had died (P = .67).CONCLUSIONS AND RELEVANCE Routine daily treatment with 20 mg of fluoxetine did not decrease the proportion of people affected by clinically significant symptoms of depression after a stroke, nor did it affect the proportion of people prescribed an antidepressant or receiving nonpharmacologic treatments compared with placebo.