Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate

被引:8
|
作者
Wilens, Timothy E. [1 ,2 ,3 ]
Faraone, Stephen, V [5 ]
Hammerness, Paul G. [4 ,6 ]
Pliszka, Steven R. [7 ]
Uchida, Cassandra L. [8 ]
DeSousa, Norberto J. [9 ]
Sallee, Floyd R. [11 ]
Incledon, Bev [10 ]
Newcorn, Jeffrey H. [12 ]
机构
[1] Massachusetts Gen Hosp, Child & Adolescent Psychiat, Boston, MA 02114 USA
[2] Massachusetts Gen Hosp, Ctr Addict Med, Boston, MA 02114 USA
[3] Harvard Med Sch, Psychiat, Boston, MA 02115 USA
[4] Harvard Med Sch, Dept Psychiat, Psychiat, Boston, MA 02115 USA
[5] SUNY Upstate Med Univ, Syracuse, NY 13210 USA
[6] Boston Childrens Hosp, Outpatient Psychiat Serv, Boston, MA USA
[7] Univ Texas Hlth Sci Ctr San Antonio, Dept Psychiat, San Antonio, TX 78229 USA
[8] Highland Therapeut Inc, Toronto, ON, Canada
[9] Ironshore Pharmaceut & Dev Inc, Clin Operat, Camana Bay, Grand Cayman, Cayman Islands
[10] Ironshore Pharmaceut & Dev Inc, Res & Dev, Camana Bay, Grand Cayman, Cayman Islands
[11] Ironshore Pharmaceut Inc, Durham, NC USA
[12] Mt Sinai Med Ctr, Psychiat & Pediat, New York, NY 10029 USA
关键词
ADHD; methylphenidate; functional impairment; BSFQ; PREMB-R; ATTENTION-DEFICIT/HYPERACTIVITY DISORDER; DEFICIT HYPERACTIVITY DISORDER; UNITED-STATES; ADOLESCENTS;
D O I
10.1177/10870547211020073
中图分类号
B844 [发展心理学(人类心理学)];
学科分类号
040202 ;
摘要
Objective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior-Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful. Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression-Improvement (CGI-I) = 1 and CGI-I <= 2. Percentages of participants achieving these thresholds were calculated. Results: Thresholds for CGI-I = 1/CGI-I <= 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all p < .05). Conclusion: DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.
引用
收藏
页码:696 / 705
页数:10
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