安慰剂
临床全球印象
注意缺陷多动障碍
医学
临床终点
评定量表
随机对照试验
临床试验
内科学
心理学
精神科
发展心理学
病理
替代医学
作者
Lenard A. Adler,Robert Goldman,Seth C. Hopkins,Kenneth S. Koblan,Justine Kent,Jay Hsu,Antony Loebel
出处
期刊:International Clinical Psychopharmacology
[Ovid Technologies (Wolters Kluwer)]
日期:2021-03-12
卷期号:36 (3): 117-125
被引量:3
标识
DOI:10.1097/yic.0000000000000333
摘要
In a previous study, dasotraline demonstrated efficacy at a dose of 8 mg/day in adults with attention deficit hyperactivity disorder (ADHD). The aim of the current study was to evaluate the efficacy and safety of dasotraline in doses of 4 and 6 mg/day. Adults meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria for ADHD were randomized to 8 weeks of double-blind, once-daily, fixed-dose treatment with dasotraline 4 mg/day, 6 mg/day, or placebo. The primary efficacy endpoint was changed in the ADHD Rating Scale, Version IV (ADHD RS-IV) total score. Secondary efficacy endpoints included the Clinical Global Impression, Severity (CGI-S) Scale. Least squares mean reduction at week 8 in the ADHD RS-IV HV total score was not significantly greater (vs. placebo) in the dasotraline 4 mg/day group (-15.0 vs. -13.9; n.s.; or in the dasotraline 6 mg/day group (-16.5 vs. -13.9; P = 0.074; Hochberg correction). Treatment with dasotraline 6 mg/day was significant at week 8 (uncorrected) on the ADHD RS-IV total score (P = 0.037) and the CGI-S score (P = 0.011). Treatment with the 4 mg/day dose of dasotraline was NS. Treatment with dasotraline was generally well tolerated. The results provide additional evidence that supports the potential efficacy of dasotraline, in doses of 6 mg/day, in adults with ADHD.
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