From the Division of Psychiatry, Faculty of Brain Sciences (Gemma Lewis, L.D., M.K., P.L., F.B., M.B., Glyn Lewis), the Research Department of Primary Care and Population Health and Priment Clinical Trials Unit (L.M., R.H., I.N., C.S.C.), and the Institute of Clinical Trials and Methodology (N.F.), University College London, London, the Department of Health Sciences and Hull York Medical School, University of York, York (S.G., S.B., J.P.), Primary Care Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton (T.K., M.M., A.H.), and Population Health Sciences (D.K.) and the Centre for Academic Mental Health (N.W., A.B.), Bristol Medical School, University of Bristol, Bristol - all in the United Kingdom; and the Department of Family Medicine, McMaster University, Hamilton, ON, Canada (D.M.).
N Engl J Med. 2021 Sep 30;385(14):1257-1267. doi: 10.1056/NEJMoa2106356.
Patients with depression who are treated in primary care practices may receive antidepressants for prolonged periods. Data are limited on the effects of maintaining or discontinuing antidepressant therapy in this setting.
We conducted a randomized, double-blind trial involving adults who were being treated in 150 general practices in the United Kingdom. All the patients had a history of at least two depressive episodes or had been taking antidepressants for 2 years or longer and felt well enough to consider stopping antidepressants. Patients who had received citalopram, fluoxetine, sertraline, or mirtazapine were randomly assigned in a 1:1 ratio to maintain their current antidepressant therapy (maintenance group) or to taper and discontinue such therapy with the use of matching placebo (discontinuation group). The primary outcome was the first relapse of depression during the 52-week trial period, as evaluated in a time-to-event analysis. Secondary outcomes were depressive and anxiety symptoms, physical and withdrawal symptoms, quality of life, time to stopping an antidepressant or placebo, and global mood ratings.
A total of 1466 patients underwent screening. Of these patients, 478 were enrolled in the trial (238 in the maintenance group and 240 in the discontinuation group). The average age of the patients was 54 years; 73% were women. Adherence to the trial assignment was 70% in the maintenance group and 52% in the discontinuation group. By 52 weeks, relapse occurred in 92 of 238 patients (39%) in the maintenance group and in 135 of 240 (56%) in the discontinuation group (hazard ratio, 2.06; 95% confidence interval, 1.56 to 2.70; P<0.001). Secondary outcomes were generally in the same direction as the primary outcome. Patients in the discontinuation group had more symptoms of depression, anxiety, and withdrawal than those in the maintenance group.
Among patients in primary care practices who felt well enough to discontinue antidepressant therapy, those who were assigned to stop their medication had a higher risk of relapse of depression by 52 weeks than those who were assigned to maintain their current therapy. (Funded by the National Institute for Health Research; ANTLER ISRCTN number, ISRCTN15969819.).
在初级保健诊所接受治疗的抑郁症患者可能会长期服用抗抑郁药。关于在此环境下维持或停止抗抑郁治疗的效果，数据有限。
我们进行了一项随机、双盲试验，涉及在英国 150 家普通诊所接受治疗的成年人。所有患者均有至少两次抑郁发作史，或服用抗抑郁药 2 年以上，且感觉足够好可以考虑停止服用抗抑郁药。接受西酞普兰、氟西汀、舍曲林或米氮平治疗的患者按 1:1 的比例随机分配，维持当前的抗抑郁治疗（维持组）或逐渐减少并停止使用匹配安慰剂的治疗（停药组）。主要结局是在 52 周试验期间首次复发抑郁，采用时间事件分析进行评估。次要结局是抑郁和焦虑症状、躯体和戒断症状、生活质量、停止服用抗抑郁药或安慰剂的时间以及整体情绪评分。
共有 1466 名患者接受了筛选。其中 478 名患者入组试验（维持组 238 名，停药组 240 名）。患者的平均年龄为 54 岁；73%为女性。维持组的试验分配依从率为 70%，停药组为 52%。52 周时，维持组 238 名患者中有 92 名（39%）复发，停药组 240 名患者中有 135 名（56%）复发（风险比，2.06；95%置信区间，1.56 至 2.70；P<0.001）。次要结局通常与主要结局一致。停药组患者的抑郁、焦虑和戒断症状比维持组更严重。
在初级保健诊所感觉足够好可以停止抗抑郁治疗的患者中，与继续当前治疗相比，被分配停止用药的患者在 52 周时出现抑郁复发的风险更高。（由英国国家卫生研究院资助；ANTLER ISRCTN 编号，ISRCTN83610149。）
