Adler Lenard A, Clemow David B, Williams David W, Durell Todd M
Departments of Psychiatry and Child and Adolescent Psychiatry, New York University, New York, New York, United States of America.
Lilly USA, LLC, Indianapolis, Indiana, United States of America.
PLoS One. 2014 Aug 22;9(8):e104175. doi: 10.1371/journal.pone.0104175. eCollection 2014.
To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder (ADHD).
In this Phase 4, multi-center, double-blind, placebo-controlled trial, young adults (18-30 years) with ADHD were randomized to receive atomoxetine (20-50 mg BID, N = 220) or placebo (N = 225) for 12 weeks. The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning. Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model (terms: baseline score, treatment, and investigator).
At baseline, there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores ≥60 (p>.5), with over 92% of patients having composite scores ≥60 (≥60 deemed clinically meaningful for these analyses). At endpoint, statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite (GEC), Behavioral Regulation Index (BRI), and Metacognitive Index (MI) scores, as well as the Inhibit, Self-Monitor, Working Memory, Plan/Organize and Task Monitor subscale scores (p<.05), with decreases in scores signifying improvements in executive functioning. Changes in the BRIEF-A Initiate (p = .051), Organization of Materials (p = .051), Shift (p = .090), and Emotional Control (p = .219) subscale scores were not statistically significant. In addition, the validity scales: Inconsistency (p = .644), Infrequency (p = .097), and Negativity (p = .456) were not statistically significant, showing scale validity.
Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales.
ClinicalTrials.gov NCT00510276.
评估托莫西汀治疗对患有注意力缺陷多动障碍（ADHD）的年轻成年人执行功能的影响。
在这项4期、多中心、双盲、安慰剂对照试验中，将患有ADHD的年轻成年人（18 - 30岁）随机分为接受托莫西汀（20 - 50 mg，每日两次，N = 220）或安慰剂（N = 225）治疗12周。成人执行功能行为评定量表（BRIEF - A）由9个非重叠临床量表中的75个自我报告项目组成，用于测量执行功能的各个方面。使用协方差分析模型（因素：基线分数、治疗和研究者）分析BRIEF - A从基线到12周终点的平均变化。
在基线时，BRIEF - A综合或指数T分数≥60的患者百分比在治疗组之间无显著差异（p > 0.5），超过92%的患者综合分数≥60（≥60被认为对这些分析具有临床意义）。在终点时，与安慰剂组相比，托莫西汀组在BRIEF - A总体执行综合评分（GEC）、行为调节指数（BRI）和元认知指数（MI）得分以及抑制、自我监控、工作记忆、计划/组织和任务监控子量表得分方面，平均降低幅度在统计学上显著更大（p < 0.05），得分降低表明执行功能有所改善。BRIEF - A启动（p = 0.051）、材料组织（p = 0.051）、转换（p = 0.090）和情绪控制（p = 0.219）子量表得分的变化无统计学意义。此外，效度量表：不一致性（p = 0.644）、低频性（p = 0.097）和消极性（p = 0.456）无统计学意义，表明量表有效。
通过BRIEF - A量表变化测量，与安慰剂组相比，患有ADHD的年轻成年人中，托莫西汀组在执行功能方面有统计学上显著更大的改善。
ClinicalTrials.gov NCT00510276。
