A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression.
A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression.
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DOI：
10.1001/archpsyc.1997.01830230069010
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发表时间：
1997-11
影响因子：
--
通讯作者：
G. Emslie;A. Rush;W. Weinberg;R. Kowatch;C. Hughes;T. Carmody;J. Rintelmann
中科院分区：
文献类型：
--
作者：
G. Emslie;A. Rush;W. Weinberg;R. Kowatch;C. Hughes;T. Carmody;J. Rintelmann
背景抑郁症是儿童和青少年发病和死亡的主要原因。迄今为止，抗抑郁药（主要是三环类药物）的随机、对照、双盲试验尚未显示任何抗抑郁药比安慰剂更有效。本文是一项关于氟西汀治疗儿童和青少年抑郁症的随机、双盲、安慰剂对照试验。方法96例儿童和青少年非精神病性抑郁症门诊患者（年龄7-17岁）随机（按年龄和性别分层）接受氟西汀或安慰剂治疗，每周一次，连续8周。随机化之前进行3次评估访视，包括2周内的结构化诊断访谈，1周后进行1周单盲安慰剂导入。主要结果测量是临床总体抑郁量表和儿童抑郁评定量表的总体改善-修订版，一种衡量抑郁症状严重程度的方法。结果：96例患者中，48例随机接受氟西汀治疗，48例接受安慰剂治疗。使用意向治疗样本，27例（56%）接受氟西汀治疗的患者和16例（33%）接受安慰剂治疗的患者在研究退出时的临床总体不可接受性量表上被评为“很大”或“非常大”改善（卡方2 = 5.1，df = 1，P = .02）。在治疗5周后修订的儿童抑郁评定量表（使用末次观察值结转）的每周评分中也观察到显著差异。12岁及以下患者（n = 48）和13岁及以上患者（n = 48）的缓解率相同。然而，只有31%的氟西汀治疗患者和23%的安慰剂治疗患者出现完全症状缓解（儿童抑郁评定量表-修订版<或= 28）。结论氟西汀治疗儿童青少年重度持续性抑郁症急性期疗效优于安慰剂，且具有上级疗效。症状完全缓解是罕见的。
BACKGROUND Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. METHODS Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale--Revised, a measure of the severity depressive symptoms. RESULTS Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated "much" or "very much" improved on the Clinical Global Impressions scale at study exit (chi 2 = 5.1, df = 1, P = .02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale--Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n = 48) and those aged 13 years and older (n = 48). However, complete symptom remission (Children's Depression Rating Scale--Revised < or = 28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. CONCLUSION Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.