Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
2011年7月25日 更新者：Eli Lilly and Company
An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder
The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD
研究概览
研究类型
介入性
注册 (实际的)
45
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aichi、日本、466-8560
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiba、日本、272-8516
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukushima、日本、960-1295
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hokkaido、日本、060-8648
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo、日本、661-0002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ishikawa、日本、920-8641
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanagawa、日本、259-1193
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kumamoto、日本、862-0920
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kyoto、日本、606-8507
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nara、日本、634-8522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saitama、日本、350-0495
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo、日本、160-0023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- at least 18 years of age
- meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
- have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Exclusion Criteria:
- Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the Hamilton Depression Rating Scale-17 items (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
- Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
- Patients who have any history of bipolar disorder (DSM-IV), any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
- Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：托莫西汀
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40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Number of Participants With Adverse Events Leading to Discontinuation
大体时间：over 8 weeks
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over 8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
大体时间：baseline and 8 weeks
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Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently).
Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.
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baseline and 8 weeks
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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
大体时间：baseline and 8 weeks
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Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently).
Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.
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baseline and 8 weeks
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Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
大体时间：baseline and 8 weeks
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Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
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baseline and 8 weeks
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Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
大体时间：baseline and 8 weeks
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The 17-item HAMD measures depression severity.
Each item was evaluated and scored using either a 5-point scale (e.g.
absent, mild, moderate, severe, very severe) or a 3-point scale (e.g.
absent, mild, marked).
The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
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baseline and 8 weeks
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Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
大体时间：baseline and 8 weeks
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The 14-item HAMA assesses the severity of anxiety.
The investigator talked to the patient about their symptoms over the previous week before the study visit.
Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe.
The total score of HAMA-14 may range from 0 (normal) to 56 (severe).
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baseline and 8 weeks
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Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
大体时间：baseline and 8 weeks
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Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales. Calculate: norm-based score=Z-score*10+50 in each subscale. |
baseline and 8 weeks
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Change From Endpoint to Baseline in Stroop Color Word Test
大体时间：baseline and 8 weeks
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An assessment of response inhibition.
Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink.
There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.
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baseline and 8 weeks
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Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
大体时间：over 8 weeks
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Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
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over 8 weeks
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Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
大体时间：over 8 weeks
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Potentially clinically significant weight loss was defined as any decrease of at least 7%.
Potentially clinically significant weight gain was defined as any increase of at least 7%.
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over 8 weeks
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Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
大体时间：over 8 weeks
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The Fridericia correction of the QT interval(QTcF) was used.
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over 8 weeks
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Cytochrome P450 2D6 (CYP2D6) Phenotype Status
大体时间：8 weeks
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CYP2D6 is the primary atomoxetine metabolizing enzyme.
Metabolizer status was determined by focusing on the normal, decreased, and defective allele.
Poor metabolizer = defective/defective.
Extensive metabolizer is all except for poor metabolizer.
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8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年9月1日
初级完成 (实际的)
2008年4月1日
研究完成 (实际的)
2008年4月1日
研究注册日期
首次提交
2007年9月14日
首先提交符合 QC 标准的
2007年9月14日
首次发布 (估计)
2007年9月17日
研究记录更新
最后更新发布 (估计)
2011年7月27日
上次提交的符合 QC 标准的更新
2011年7月25日
最后验证
2011年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.