阿托莫西汀
哌醋甲酯
药物治疗
临床试验
加药
安慰剂
食品药品监督管理局
药品
兴奋剂
标签外使用
心理学
试用登记
托莫西汀
梅德林
精神科
医学
注意缺陷多动障碍
药理学
替代医学
内科学
病理
法学
政治学
作者
Craig Surman,Daniel M. Walsh,Joseph B. Bond
标识
DOI:10.1177/10870547231218041
摘要
Objective: We appraised whether FDA registration trials for ADHD pharmacotherapy in adults provides comparable information to inform treatment expectations. Method: Comparison of ADHD outcome measure patterns in ADHD pharmacotherapy FDA drug label source studies. Results: Among stimulants, from fixed-dose titration data, amphetamine agents had numerically higher placebo-corrected symptom improvement and symptom effect sizes than methylphenidate agents. Symptom effect sizes were lower in the flexible dosing registration studies of atomoxetine and viloxazine. Varying responder definitions were analyzable, based on ≥30% symptom improvement and/or CGI-I improvement of “much” or “very much improved.” Number of exposures needed to create these responses were lower for stimulants than for viloxazine. Conclusion: Heterogeneity in the design and analysis of FDA drug label source trials restricts implications for clinical practice. Research conducted using replicated designs, direct comparison of available treatments, and outcome analyses that generalize to clinical care could better inform clinical decision making.
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