Biederman Joseph, Pliszka Steven R
Pediatric Psychopharmacology Unit, Massachusetts General Hospital, Boston, MA, USA.
J Pediatr. 2008 Mar;152(3):394-9. doi: 10.1016/j.jpeds.2007.07.052. Epub 2007 Oct 24.
This secondary analysis evaluated the efficacy of modafinil in children and adolescents by subtype of attention-deficit/hyperactivity disorder (ADHD) using pooled data from 3 double-blind, placebo-controlled studies.
The patients were boys and girls age 6 to 17 years. ADHD subtype diagnoses (ie, inattentive, hyperactive-impulsive, combined) were based on criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Patients received modafinil (170 to 425 mg) or placebo once daily for 7 to 9 weeks. Efficacy assessment used the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) School and Home Versions, Clinical Global Impression of Improvement scale (CGI-I), and Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S).
A total of 638 patients received modafinil (n = 423) or placebo (n = 215). The inattentive, hyperactive-impulsive, and combined subtypes included 187 (30%), 27 (4%), and 403 (65%) patients, respectively. Modafinil (vs placebo) significantly improved mean total scores for the ADHD-RS-IV School and Home Versions for the inattentive (change from baseline: School, modafinil, -15.7, placebo, -7.1; Home, modafinil, -13.8, placebo, -5.9) and combined subtypes (School, -16.5 vs -8.8; Home, -15.7 vs -7.6). Modafinil was associated with greater improvements on the CGI-I and improved CPRS-R:S subscale scores in inattentive and combined subtypes.
Modafinil improved ADHD symptoms and behaviors in patients with the inattentive and combined subtypes as determined by teachers, investigators, and parents.
本二次分析使用来自3项双盲、安慰剂对照研究的汇总数据,按注意力缺陷多动障碍(ADHD)亚型评估莫达非尼在儿童和青少年中的疗效。
患者为6至17岁的男孩和女孩。ADHD亚型诊断(即注意力不集中型、多动冲动型、混合型)基于美国精神病学协会《精神疾病诊断与统计手册》第四版(DSM-IV)中公布的标准。患者每天接受一次莫达非尼(170至425毫克)或安慰剂治疗,持续7至9周。疗效评估使用注意力缺陷/多动障碍评定量表-IV(ADHD-RS-IV)学校版和家庭版、临床总体改善印象量表(CGI-I)以及康纳斯父母评定量表修订版:简表(CPRS-R:S)。
共有638例患者接受了莫达非尼(n = 423)或安慰剂(n = 215)治疗。注意力不集中型、多动冲动型和混合型分别包括187例(30%)、27例(4%)和403例(65%)患者。莫达非尼(与安慰剂相比)显著改善了注意力不集中型(与基线相比的变化:学校版,莫达非尼,-15.7,安慰剂,-7.1;家庭版,莫达非尼,-13.8,安慰剂,-5.9)和混合型(学校版,-16.5对-8.8;家庭版,-15.7对-7.6)ADHD-RS-IV学校版和家庭版量表的平均总分。莫达非尼与注意力不集中型和混合型患者在CGI-I上的更大改善以及CPRS-R:S子量表得分的改善相关。
根据教师、研究人员和家长的评估,莫达非尼改善了注意力不集中型和混合型患者的ADHD症状及行为。