NCT00636818已完成2 期
An Open Study of Atomoxetine (LY139603) 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
- Discontinuations Due to Adverse Events (AE)
研究概览
简要总结
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 Impressions-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 17-item Hamilton Depression Rating Scale (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
Discontinuations Due to Adverse Events (AE)
时间窗: Baseline to 8 Weeks
The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
次要结局
- Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score(Baseline and 8 Weeks)
- Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)(Baseline and 8 Weeks)
- Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score(Baseline and 8 Weeks)
- Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)(Baseline and 8 Weeks)
- Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)(Baseline and 8 Weeks)
- Change From Baseline to 8 Week Endpoint in Stroop Color Word Test(Baseline and 8 Weeks)
- Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)(Baseline and 8 Weeks)
- Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study(Baseline to 8 Weeks)
- Significant Changes in Body Weight During the Study(Baseline to 8 Weeks)
- Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion(Baseline to 8 Weeks)
- Cytochrome P450 2D6 (CYP2D6) Phenotype Status(8 Weeks)
研究者
研究点 (1)
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