Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism.
Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism.
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DOI：
10.1001/archgenpsychiatry.2009.30
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发表时间：
2009-06
影响因子：
--
通讯作者：
Ritz, Louise
中科院分区：
文献类型：
--
作者：
King, Bryan H.;Hollander, Eric;Sikich, Linmarie;McCracken, James T.;Scahill, Lawrence;Bregman, Joel D.;Donnelly, Craig L.;Anagnostou, Evdokia;Dukes, Kimberly;Sullivan, Lisa;Hirtz, Deborah;Wagner, Ann;Ritz, Louise
选择性5-羟色胺再摄取抑制剂被广泛用于自闭症谱系障碍儿童。确定西酞普兰氢溴酸盐治疗自闭症谱系障碍儿童重复行为的有效性和安全性。国立卫生研究院申办的随机对照试验。六个学术中心，包括西奈山医学院、北岸-长岛犹太卫生系统、查佩尔山的北卡罗来纳州大学、洛杉矶的加州大学、耶鲁大学和达特茅斯医学院。149名5 - 17岁的志愿者（平均[SD]年龄，9.4 [3.1]岁）被随机分配接受西酞普兰（n = 73）或安慰剂（n = 76）。受试者患有自闭症谱系障碍、自闭症障碍或广泛性发育障碍（未另行说明）;在临床总体冲动、疾病严重程度量表上，疾病严重程度评级至少为中度;在使用针对广泛性发育障碍修改的儿童耶鲁-布朗强迫量表测量的强迫行为上，得分至少为中度。氢溴酸西酞普兰（10 mg/5 mL）或安慰剂治疗12周。口服氢溴酸西酞普兰的平均（SD）最大剂量为16.5（6.5）mg/d（最大剂量为20 mg/d）。阳性应答定义为临床总体改善、改善子量表评分大幅改善或非常显著改善。一个重要的次要结果是儿童耶鲁-布朗强迫量表的评分，该量表针对广泛性发育障碍进行了修改。使用安全性监测统一报告表系统性地引出不良事件。西酞普兰治疗组（32.9%）和安慰剂组（34.2%）在临床总体疗效、改善子量表的阳性应答率方面无显著差异（相对风险，0.96; 95%可信区间，0.61-1.51; P> 0.99）。儿童耶鲁-布朗强迫症量表中广泛性发育障碍的评分降低与基线相比没有差异（平均值[SD]，西酞普兰治疗组为-2.0 [3.4]分，安慰剂组为-1.9 [2.5]分; P= 0.81）。西酞普兰的使用明显更可能与不良事件相关，特别是能量水平升高、冲动、注意力下降、多动、刻板、腹泻、失眠和皮肤干燥或瘙痒。本试验的结果不支持使用西酞普兰治疗自闭症谱系障碍儿童和青少年的重复行为。clinicaltrials.gov标识符：NCT 00086645
Selective serotonin reuptake inhibitors are widely prescribed for children with autism spectrum disorders. To determine the efficacy and safety of citalopram hydrobromide therapy for repetitive behavior in children with autism spectrum disorders. National Institutes of Health–sponsored randomized controlled trial. Six academic centers, including Mount Sinai School of Medicine, North Shore–Long Island Jewish Health System, University of North Carolina at Chapel Hill, University of California at Los Angeles, Yale University, and Dartmouth Medical School. One hundred forty-nine volunteers 5 to 17 years old (mean [SD] age, 9.4 [3.1] years) were randomized to receive citalopram (n = 73) or placebo (n = 76). Participants had autistic spectrum disorders, Asperger disorder, or pervasive developmental disorder, not otherwise specified; had illness severity ratings of at least moderate on the Clinical Global Impressions, Severity of Illness Scale; and scored at least moderate on compulsive behaviors measured with the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders. Twelve weeks of citalopram hydrobromide (10 mg/5 mL) or placebo. The mean (SD) maximum dosage of citalopram hydrobromide was 16.5 (6.5) mg/d by mouth (maximum, 20 mg/d). Positive response was defined by a score of much improved or very much improved on the Clinical Global Impressions, Improvement subscale. An important secondary outcome was the score on the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders. Adverse events were systematically elicited using the Safety Monitoring Uniform Report Form. There was no significant difference in the rate of positive response on the Clinical Global Impressions, Improvement subscale between the citalopram-treated group (32.9%) and the placebo group (34.2%) (relative risk, 0.96; 95% confidence interval, 0.61-1.51; P> .99). There was no difference in score reduction on the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders from baseline (mean [SD], −2.0 [3.4] points for the citalopram-treated group and −1.9 [2.5] points for the placebo group; P=.81). Citalopram use was significantly more likely to be associated with adverse events, particularly increased energy level, impulsiveness, decreased concentration, hyperactivity, stereotypy, diarrhea, insomnia, and dry skin or pruritus. Results of this trial do not support the use of citalopram for the treatment of repetitive behavior in children and adolescents with autism spectrum disorders. clinicaltrials.gov Identifier: NCT00086645
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影响因子：
8
作者：
Mandell, David S.;Morales, Knashawn H.;Polsky, Daniel E.
通讯作者：
Polsky, Daniel E.
DOI：
10.1089/104454602760386932
发表时间：
2002-09-01
影响因子：
1.9
作者：
Couturier, JL;Nicolson, R
通讯作者：
Nicolson, R
影响因子：
4.1
作者：
Bramble, David
通讯作者：
Bramble, David
影响因子：
158.5
作者：
McCracken, JT;McGough, J;McMahon, D
通讯作者：
McMahon, D
DOI：
10.1097/01.chi.0000231976.28719.2a
发表时间：
2006-10-01
影响因子：
13.3
作者：
Arnold, L. Eugene;Aman, Michael G.;Ramadan, Yaser
通讯作者：
Ramadan, Yaser