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. Trial Registration http://anzctr.org.au Identifier: ACTRN12611000774921.

中文翻译：

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接受氟西汀治疗以恢复中风的患者的抑郁结果：AFFINITY 随机临床试验。

重要性三分之一的成年人在中风后的第一年会出现临床上显着的抑郁症状，但支持在这一人群中使用抗抑郁药的证据仍然很少。目的 探讨每日服用 20 mg 盐酸氟西汀治疗能否降低卒中后出现临床显着抑郁症状的人群比例。设计、设置和参与者 在这项对氟西汀在中风恢复中的评估的二次分析中，平行组、随机（1:1 分配）、双盲、安慰剂对照临床试验，澳大利亚、新西兰和越南的 1221 名参与者于 2013 年 1 月 11 日至 2019 年 6 月 30 日期间入组，随访 6 个月。18 岁或以上的成年人在经历与改良 Rankin 量表评分为 1 或更高相关的中风后 2 至 15 天被招募。干预措施 盐酸氟西汀，20 毫克，或每天匹配安慰剂，持续 26 周。主要结果和措施 9 项患者健康问卷 (PHQ-9) 得分为 9 分或更低是试验的预设次要结果。评估在基线和 4、12 和 26 周完成。其他感兴趣的结果包括参与者报告的临床医生诊断为抑郁症、非试验性抗抑郁药的处方或抑郁症的非药物治疗。分析是在意向治疗的基础上进行的。结果 共有 607 名参与者（378 名男性 [62.3%]；平均 [SD] 年龄，64.3 [12.2] 岁）被随机分配接受安慰剂治疗，614 名参与者（397 名男性 [64.7%]；平均 [SD] 年龄，63.4 [12.4] 岁）被随机分配每天服用 20 mg 盐酸氟西汀治疗。这些组在人口统计学和临床​​测量方面是平衡的。基线时，安慰剂组 112 名患者（18.5%）和氟西汀组 116 名患者（18.9%）的 PHQ-9 评分为 9 分或更高。在随访期间，接受安慰剂治疗的 596 名参与者中的 126 名（21.1%）和接受氟西汀治疗的 598 名参与者中的 121 名（20.2%）的 PHQ-9 评分为 9 分或更高（P = .70）。在基线时 PHQ-9 评分低于 9 分且接受盐酸氟西汀和安慰剂治疗的参与者中，相似比例的参与者在试验期间的 PHQ-9 评分为 9 分或更高（安慰剂，488 人中的 72 人 [14.8%]；氟西汀，63 485 [13.0%]；P = .43)。安慰剂组参与者报告的临床医生诊断为抑郁症的人数略多于氟西汀组（602 人中有 42 人 [7.0%] vs 601 人中有 26 人 [4.3%]；P = .05）。到第 26 周，安慰剂组 14 名参与者 (2.3%) 和氟西汀组 12 名参与者 (1.9%) 死亡 (P = .67)。结论和相关性 与安慰剂相比，每天使用 20 mg 氟西汀进行常规治疗并未降低中风后受临床显着抑郁症状影响的人群比例，也不影响开具抗抑郁药或接受非药物治疗的人群比例。试用注册 http://anzctr.org.au 标识符：ACTRN12611000774921。安慰剂组 3%) 和氟西汀组 12 名参与者 (1.9%) 死亡 (P = .67)。结论和相关性 与安慰剂相比，每天使用 20 mg 氟西汀进行常规治疗并未降低中风后受临床显着抑郁症状影响的人群比例，也不影响开具抗抑郁药或接受非药物治疗的人群比例。试用注册 http://anzctr.org.au 标识符：ACTRN12611000774921。安慰剂组 3%) 和氟西汀组 12 名参与者 (1.9%) 死亡 (P = .67)。结论和相关性 与安慰剂相比，每天使用 20 mg 氟西汀进行常规治疗并未降低中风后受临床显着抑郁症状影响的人群比例，也不影响开具抗抑郁药或接受非药物治疗的人群比例。试用注册 http://anzctr.org.au 标识符：ACTRN12611000774921。与安慰剂相比，它也不影响开抗抑郁药或接受非药物治疗的人的比例。试用注册 http://anzctr.org.au 标识符：ACTRN12611000774921。与安慰剂相比，它也不影响开抗抑郁药或接受非药物治疗的人的比例。试用注册 http://anzctr.org.au 标识符：ACTRN12611000774921。