NCT00530335已完成2 期
An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events Leading to Discontinuation
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
Atomoxetine
Experimental
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Number of Participants With Adverse Events Leading to Discontinuation
时间窗: over 8 weeks
次要结局
- Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)(baseline and 8 weeks)
- Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)(baseline and 8 weeks)
- Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity(baseline and 8 weeks)
- Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score(baseline and 8 weeks)
- Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score(baseline and 8 weeks)
- Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores(baseline and 8 weeks)
- Change From Endpoint to Baseline in Stroop Color Word Test(baseline and 8 weeks)
- Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study(over 8 weeks)
- Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study(over 8 weeks)
- Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion(over 8 weeks)
- Cytochrome P450 2D6 (CYP2D6) Phenotype Status(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASDAttention Deficit Hyperactivity DisorderNCT00485849Eli Lilly and Company12
已完成
2 期
Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity DisorderNCT00636818Eli Lilly and Company45
已完成
4 期
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHDAttention-Deficit/Hyperactivity DisorderComorbid DyslexiaNCT00191048Eli Lilly and Company105
已完成
3 期
Long-Term, Open Label Atomoxetine StudyAttention Deficit Hyperactivity DisorderNCT00190684Eli Lilly and Company1,553
已完成
3 期
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and AdolescentsAttention Deficit Hyperactivity DisorderNCT00447278Eli Lilly and Company399