Keller M B, Ryan N D, Strober M, Klein R G, Kutcher S P, Birmaher B, Hagino O R, Koplewicz H, Carlson G A, Clarke G N, Emslie G J, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack W H, Sweeney M, Wagner K D, Weller E B, Winters N C, Oakes R, McCafferty J P
Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI 02906, USA.
J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):762-72. doi: 10.1097/00004583-200107000-00010.
To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression.
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 < or = 8 or > or = 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.
Paroxetine demonstrated significantly greater improvement compared with placebo in HAM-D total score < or = 8, 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.
Paroxetine is generally well tolerated and effective for major depression in adolescents.
比较帕罗西汀与安慰剂以及丙咪嗪与安慰剂治疗青少年抑郁症的效果。
经过7至14天的筛查期后，275名重度抑郁症青少年开始为期8周的双盲治疗，分别服用帕罗西汀（20 - 40毫克）、丙咪嗪（逐渐递增至200 - 300毫克）或安慰剂。两项主要结局指标为终点反应（汉密尔顿抑郁量表[HAM - D]评分≤8或基线HAM - D评分降低≥50%）以及HAM - D评分相对于基线的变化。其他与抑郁相关的变量包括：（1）HAM - D的抑郁情绪项目；（2）青少年情感障碍与精神分裂症量表终身版（K - SADS - L）的抑郁项目；（3）临床总体印象（CGI）改善评分为1或2；（4）K - SADS - L的九项抑郁子量表；（5）平均CGI改善评分。
在HAM - D总分≤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，帕罗西汀与安慰剂相比有显著更大的改善。对于任何指标，丙咪嗪与安慰剂的反应均无显著差异。在家长或自评指标方面，帕罗西汀和丙咪嗪与安慰剂均无显著差异。帕罗西汀和安慰剂因不良反应的撤药率分别为9.7%和6.9%。在因不良反应停止丙咪嗪治疗的受试者中，31.5%的人中有近三分之一是因为心血管不良反应。
帕罗西汀对青少年重度抑郁症总体耐受性良好且有效。
