Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial
Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial
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DOI：
10.1097/00004583-200107000-00010
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发表时间：
2001-07-01
影响因子：
13.3
通讯作者：
McCafferty, JP
中科院分区：
文献类型：
--
作者：
Keller, MB;Ryan, ND;McCafferty, JP
目的：比较帕罗西汀与安慰剂和丙咪嗪与安慰剂治疗青少年抑郁症的效果。方法：经过 7 至 14 天的筛选期后，275 名患有重度抑郁症的青少年开始接受为期 8 周的双盲帕罗西汀（20-40 毫克）、丙咪嗪（逐渐向上滴定至 200-300 毫克）或安慰剂治疗。两个主要结果指标是终点反应（汉密尔顿抑郁量表 [HAM-D] 评分小于或等于 8 或大于或等于基线 HAM-D 降低 50%）和基线 HAM-D 评分的变化。其他与抑郁相关的变量有（1）HAM-D 抑郁情绪项目； （2）青少年情感障碍和精神分裂症终生版（K-SADS-L）抑郁症项目； (3) 临床总体印象（CGI）改善分数为1或2； (4) K-SADS-L九项抑郁量表； (5) 平均 CGI 改善分数。结果：与安慰剂相比，帕罗西汀在 HAM-D 总分小于或等于 8、HAM-D 抑郁情绪项目、K-SADS-L 抑郁情绪项目以及 CGI 评分为 1 或 2 方面表现出显着更大的改善。在任何测量方面，对丙咪嗪的反应与安慰剂没有显着差异。在家长或自我评价指标上，帕罗西汀和丙咪嗪与安慰剂均无显着差异。帕罗西汀和安慰剂因不良反应而退出的比例分别为 9.7% 和 6.9%。 31.5% 的受试者因不良反应而停止丙咪嗪治疗，其中近三分之一是因为不良心血管反应。结论：帕罗西汀对于青少年重度抑郁症总体耐受性良好且有效。
Objective: To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression. Method: After a 7- to 14-day screening period, 275 adolescents with major depression began 8 weeks of double-blind paroxetine (20-40 mg), imipramine (gradual upward titration to 200-300 mg), or placebo. The two primary outcome measures were endpoint response (Hamilton Rating Scale for Depression [HAM-D] score less than or equal to8 or greater than or equal to 50% reduction in baseline HAM-D) and change from baseline HAM-D score. Other depression-related variables were (1) HAM-D depressed mood item; (2) depression item of the Schedule for Affective Disorders and Schizophrenia for Adolescents-Lifetime version (K-SADS-L); (3) Clinical Global impression (CGI) improvement scores of 1 or 2; (4) nine-item depression subscale of K-SADS-L; and (5) mean CGI improvement scores. Results: Paroxetine demonstrated significantly greater improvement compared with placebo in HAM-D total score less than or equal to8, HAM-D depressed mood item, K-SADS-L depressed mood item, and CGI score of 1 or 2. The response to imipramine was not significantly different from placebo for any measure. Neither paroxetine nor imipramine differed significantly from placebo on parent- or self-rating measures. Withdrawal rates for adverse effects were 9.7% and 6.9% for paroxetine and placebo, respectively. Of 31.5% of subjects stopping imipramine therapy because of adverse effects, nearly one third did so because of adverse cardiovascular effects. Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents.