Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN 46285, USA.
J Clin Psychopharmacol. 2013 Feb;33(1):45-54. doi: 10.1097/JCP.0b013e31827d8a23.
Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine.
Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use.
Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P < 0.001), Clinical Global Impression-ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P < 0.001), and CAARS Self-Report (atomoxetine [-11.9 ± 0.8] vs placebo [-7.8 ± 0.7], 95% confidence interval [-5.94 to -2.15], P < 0.001) but not on Patient Global Impression-Improvement. In addition, atomoxetine was superior to placebo on Adult ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo.
Atomoxetine reduced ADHD symptoms and improved quality of life and executive functioning deficits in young adults compared with placebo. Atomoxetine was also generally well tolerated.
注意力缺陷多动障碍(ADHD)与多个功能领域的显著损害有关。本试验评估了阿托西汀治疗年轻成人 ADHD 症状和功能结局的疗效。
年轻成人(18-30 岁)患有 ADHD,随机分为 12 周双盲治疗组,接受阿托西汀(n=220)或安慰剂(n=225)治疗。ADHD 症状变化的主要疗效指标是康纳氏成人 ADHD 评定量表(CAARS):研究者评定:筛查版本总 ADHD 症状评分和成人提示。次要结局量表包括成人 ADHD 生活质量-29 量表、临床总体印象-ADHD 严重程度、患者总体印象-改善、CAARS 自我报告、行为评定量表的执行功能-成人版自我报告,以及抑郁、焦虑、嗜睡、驾驶行为、社会适应和物质使用的评估。
阿托西汀在 CAARS:研究者评定:筛查版本(阿托西汀[最小二乘均数±SE,-13.6±0.8] vs 安慰剂[-9.3±0.8],95%置信区间[-6.35 至-2.37],P<0.001)、临床总体印象-ADHD 严重程度(阿托西汀[-1.1±0.1] vs 安慰剂[-0.7±0.1],95%置信区间[-0.63 至-0.24],P<0.001)和 CAARS 自我报告(阿托西汀[-11.9±0.8] vs 安慰剂[-7.8±0.7],95%置信区间[-5.94 至-2.15],P<0.001)方面优于安慰剂,但在患者总体印象-改善方面无显著差异。此外,阿托西汀在成人 ADHD 生活质量-29 量表和行为评定量表的执行功能-成人版自我报告方面优于安慰剂。其他评估未能检测到阿托西汀与安慰剂之间有显著差异(P≥0.05)。不良反应谱与其他阿托西汀研究相似。与安慰剂相比,阿托西汀更常报告恶心、食欲下降、失眠、口干、易怒、头晕和消化不良。
与安慰剂相比,阿托西汀可降低年轻成人的 ADHD 症状,并改善生活质量和执行功能缺陷。阿托西汀通常也具有良好的耐受性。