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Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder
Takahashi, Michihiro1,2; Goto, Taro1; Takita, Yasushi1; Chung, Sang-Keun3; Wang, Yufeng4; Gau, Susan Shur-Fen5,6
关键词adult atomoxetine attention-deficit hyperactivity disorder Chinese Korean Taiwanese
刊名ASIA-PACIFIC PSYCHIATRY
2014-03-01
DOI10.1111/j.1758-5872.2012.00204.x
6期:1页:62-70
收录类别SCI ; SSCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Psychiatry
研究领域[WOS]Psychiatry
关键词[WOS]ONCE-DAILY ATOMOXETINE ; DEFICIT/HYPERACTIVITY DISORDER ; DOUBLE-BLIND ; ADHD SYMPTOMS ; ADOLESCENTS ; CHILDREN ; TRIAL ; ASSOCIATION ; PREVALENCE ; SLEEP
英文摘要

IntroductionThe primary objective of this study was to assess the overall safety and tolerability of atomoxetine in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder (ADHD).

MethodsA total of 44 patients aged 18 years who met the Conners′ Adult ADHD Diagnostic Interview for DSM-IV diagnostic criteria for ADHD were enrolled from China, Korea, and Taiwan. In this open-label, dose-escalation study, patients received atomoxetine orally once daily over a period of eight weeks, starting at 40mg/day (one week) up to a maximum dosage of 120mg/day. Tolerability was evaluated by rate of discontinuation due to adverse events. Safety was assessed by recording all adverse events, laboratory tests, vital signs, and electrocardiograms. ADHD symptoms were evaluated by the Conners′ Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) for efficacy assessment.

ResultsThirty-four patients (77.3%) completed the study. Atomoxetine was well tolerated with a discontinuation rate of 2.3% (1/44) due to adverse events. The most commonly reported adverse events were nausea, dizziness, and somnolence. The mean change from baseline to endpoint in CAARS-Inv:SV total ADHD symptom score was -12.5 (P<0.001). A significant reduction in the CAARS-Inv:SV subscales (inattentive, hyperactive/impulsive, and ADHD index score, P<0.001) was observed.

DiscussionThis is the first atomoxetine clinical trial in adult patients with ADHD in China, Korea, and Taiwan. Atomoxetine was well tolerated in doses of up to 120mg/day with no unknown safety concerns.

语种英语
WOS记录号WOS:000331552400008
资助机构Eli Lilly Japan K.K.
引用统计
被引频次:10[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/59709
专题北京大学精神卫生研究所
作者单位1.Terauchi Takahashi Psychiat Clin, Ashiya, Japan
2.Natl Taiwan Univ, Coll Med, Taipei 10764, Taiwan
3.Eli Lilly Japan KK, Lilly Res Labs Japan, Kobe, Hyogo 6510086, Japan
4.Chonbuk Natl Univ, Sch Med, Dept Psychiat, Jeonju, South Korea
5.Peking Univ, Inst Mental Hlth, Hosp Affiliated 6, Dept Child Psychiat, Beijing 100871, Peoples R China
6.Natl Taiwan Univ Hosp, Dept Psychiat, Taipei, Taiwan
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Takahashi, Michihiro,Goto, Taro,Takita, Yasushi,et al. Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder[J]. ASIA-PACIFIC PSYCHIATRY,2014,6(1):62-70.
APA Takahashi, Michihiro,Goto, Taro,Takita, Yasushi,Chung, Sang-Keun,Wang, Yufeng,&Gau, Susan Shur-Fen.(2014).Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder.ASIA-PACIFIC PSYCHIATRY,6(1),62-70.
MLA Takahashi, Michihiro,et al."Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder".ASIA-PACIFIC PSYCHIATRY 6.1(2014):62-70.
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