一项关于莫达非尼薄膜包衣片用于治疗儿童和青少年注意力缺陷/多动障碍的随机、双盲、安慰剂对照研究。

A randomized, double-blind, placebo-controlled study of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder.

作者信息

Greenhill Laurence L, Biederman Joseph, Boellner Samuel W, Rugino Thomas A, Sangal R Bart, Earl Craig Q, Jiang John G, Swanson James M

机构信息

Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.

出版信息

J Am Acad Child Adolesc Psychiatry. 2006 May;45(5):503-511. doi: 10.1097/01.chi.0000205709.63571.c9.

DOI:10.1097/01.chi.0000205709.63571.c9

PMID:16601402

Abstract

OBJECTIVE

To evaluate the efficacy and tolerability of modafinil in children and adolescents, ages 7 to 17, with attention-deficit/hyperactivity disorder (ADHD).

METHOD

In this 9-week, double-blind, flexible-dose study, patients were randomized to once-daily modafinil (170-425 mg) or placebo. Assessments included ADHD Rating Scale-IV (ADHD-RS-IV) School and Home Versions and Clinical Global Impression of Improvement (CGI-I) scale.

RESULTS

Two hundred patients were randomized. Modafinil produced significant reductions in ADHD-RS-IV total scores at school (n = 128; mean change +/- SD: -17.5 +/- 13.1 points) compared with placebo (n = 66; -9.7 +/- 10.3 points; p < .0001). Similarly, modafinil reduced ADHD-RS-IV total scores at home compared with placebo (-17.6 +/- 13.3 versus -7.5 +/- 11.8 points; p < .0001). Fifty-two percent of patients randomized to modafinil and 18% of those randomized to placebo met prestudy criteria for responder on the CGI-I (p < .0001). Randomization to modafinil was associated with significantly more insomnia, headache, decreased appetite, and weight loss than randomization to placebo, but discontinuation attributed to adverse events did not differ statistically between treatment groups (modafinil, 5%; placebo, 6%).

CONCLUSION

Modafinil was well tolerated and reduced ADHD symptoms at school and home compared with placebo.

摘要

目的

评估莫达非尼对7至17岁患有注意力缺陷多动障碍（ADHD）的儿童和青少年的疗效及耐受性。

方法

在这项为期9周的双盲、灵活剂量研究中，患者被随机分为每日一次服用莫达非尼（170 - 425毫克）或安慰剂组。评估包括ADHD评定量表-IV（ADHD-RS-IV）学校版和家庭版以及临床总体改善印象（CGI-I）量表。

结果

200名患者被随机分组。与安慰剂组（n = 66；-9.7 ± 10.3分；p <.0001）相比，莫达非尼使学校环境下ADHD-RS-IV总分显著降低（n = 128；平均变化±标准差：-17.5 ± 13.1分）。同样，与安慰剂相比，莫达非尼使家庭环境下ADHD-RS-IV总分也降低了（-17.6 ± 13.3分对-7.5 ± 11.8分；p <.0001）。随机分配到莫达非尼组的患者中有52%以及随机分配到安慰剂组的患者中有18%在CGI-I量表上达到了研究前设定的反应标准（p <.0001）。与随机分配到安慰剂组相比，随机分配到莫达非尼组出现失眠、头痛、食欲减退和体重减轻的情况明显更多，但因不良事件导致停药在治疗组之间无统计学差异（莫达非尼组为5%；安慰剂组为6%）。