The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial.
The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial.
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DOI：
10.1186/1753-2000-3-11
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发表时间：
2009-03-19
影响因子：
5.6
通讯作者：
Reed, Michael D
中科院分区：
文献类型：
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作者：
Findling, Robert L;Pagano, Maria E;Reed, Michael D
背景技术背景：本研究的目的是检查氟西汀在急性改善患有抑郁症和共病物质使用障碍的青少年的抑郁症状方面是否上级于安慰剂。符合条件的受试者，年龄12-17岁，患有当前重度抑郁症（MDD）或抑郁症，同时患有共病物质-在这项为期8周的单中心、双盲、安慰剂对照研究中，将患有相关疾病的患者随机分为氟西汀组和安慰剂组。主要结果分析是一个随机效应的混合模型，反复测量儿童抑郁量表修订版（CDRS-R）的分数比较治疗组之间的时间across time.RESULTS：一个中期分析后，34例患者进行随机化。根据无效性分析的结果，停止研究入组。29名男性和5名女性随机接受氟西汀（n = 18）或安慰剂（n = 16）。他们的平均年龄为16.5（1.1）岁。总体而言，接受氟西汀和安慰剂的患者CDRS-R评分降低。然而，在接受氟西汀治疗的受试者和接受安慰剂治疗的受试者中，CDRS-R总分的平均变化无显著差异（治疗差异= 0.19，S.E. = 0.58，F = 0.14，p = .74）。此外，在任何随机化后访视时，治疗组间尿液药物毒理学结果阳性率无显著差异（F = 0.22，df = 1，p = 0.65）。本研究的主要局限性在于样本量较小，统计功效较低。本研究的其他重要局限性包括但不限于试验的简短性、高安慰剂应答率、氟西汀的剂量范围有限以及纳入符合MDD以外抑郁障碍标准的青年。氟西汀在缓解抑郁症状或降低青少年抑郁症急性治疗中药物筛查阳性率方面并不上级安慰剂，伴随物质使用障碍。
BACKGROUND: The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder.METHODS: Eligible subjects ages 12-17 years with either a current major depressive disorder (MDD) or a depressive disorder that were also suffering from a comorbid substance-related disorder were randomized to receive either fluoxetine or placebo in this single site, 8-week double-blind, placebo-controlled study. The primary outcome analysis was a random effects mixed model for repeated measurements of Children's Depression Rating Scale-Revised (CDRS-R) scores compared between treatment groups across time.RESULTS: An interim analysis was performed after 34 patients were randomized. Based on the results of a futility analysis, study enrollment was halted. Twenty-nine males and 5 females were randomized to receive fluoxetine (n = 18) or placebo (n = 16). Their mean age was 16.5 (1.1) years. Overall, patients who received fluoxetine and placebo had a reduction in CDRS-R scores. However, there was no significant difference in mean change in CDRS-R total score in those subjects treated with fluoxetine and those who received placebo (treatment difference = 0.19, S.E. = 0.58, F = 0.14, p = .74). Furthermore, there was not a significant difference in rates of positive urine drug toxicology results between treatment groups at any post-randomization visit (F = 0.22, df = 1, p = 0.65). The main limitation of this study is its modest sample size and resulting low statistical power. Other significant limitations to this study include, but are not limited to, the brevity of the trial, high placebo response rate, limited dose range of fluoxetine, and the inclusion of youth who met criteria for depressive disorders other than MDD.CONCLUSION: Fluoxetine was not superior to placebo in alleviating depressive symptoms or in decreasing rates of positive drug screens in the acute treatment of adolescents with depression and a concomitant substance use disorder.