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学科主题: 精神卫生
题名:
Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder
作者: 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
发表日期: 2014-03-01
DOI: 10.1111/j.1758-5872.2012.00204.x
卷: 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
项目资助者: Eli Lilly Japan K.K.
WOS记录号: WOS:000331552400008
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59709
Appears in Collections:北京大学精神卫生研究所_期刊论文

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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

Recommended Citation:
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.
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