NCT00962104已完成3 期
A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride in the Treatment of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks
研究概览
简要总结
The purpose of this study is to assess the efficacy, the quality of life, and the safety of multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity disorder (ADHD).
详细描述
The treatment will be initiated at the lowest dosage 40 milligrams per day (mg/day), and it will be titrated up to 80 mg/day. Patients who are unable to tolerate a dose of at least 80 mg/day through the end of this study will be discontinued. The dosage will be titrated up to a maximum of 120 mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current attention deficit/hyperactivity disorder (ADHD) as well as criteria for a historical diagnosis of ADHD during childhood, both assessed by the Conners' Adult Attention-Deficit/Hyperactivity Disorder Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition at screening
- •Patients must have a score of 2 or greater on at least 6 items of either the inattentive or hyperactive/impulsive core subscales at randomization or screening on the rated Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-item total ADHD symptom score. In addition, their total score on the 18-item total ADHD symptom score must be 20 or greater.
- •Patients must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity score of 4 (moderate symptoms) or greater.
- •Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, required by the protocol.
- •Patients must possess an educational level and degree of understanding of the language of their country that enables them to communicate suitably with the investigator and study coordinator.
- •Patients must be able to swallow capsules.
排除标准
- •Patients who meet full DSM-IV-TR diagnostic criteria for any history of bipolar disorder or any history of schizophrenia and other psychotic disorders, or patients who had received injectable sustained-release neuroleptics.
- •Patients with depressive disorder who also have a total score of 12 or greater on the Hamilton Depression Rating Scale-17 items at randomization. Patients who have both a current or past history of major depression and received any anti-depression drug therapy within 6 months of screening.
- •Patients who meet DSM-IV-TR diagnostic criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy, except for those taking benzodiazepine analogs for anxiety, which need to be limited.
- •Patients who have been diagnosed (DSM-IV-TR) with a pervasive developmental disorder.
- •Patients who, in the opinion of the investigator, are at serious suicidal risk or serious risk of harming others, or whose score for Item 11 on the Hamilton Depression Rating Scale-17 items is equal or more than 2 at randomization or screening.
- •Patients who have received atomoxetine in a prior clinical study.
- •Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine.
- •Patients with a history of allergy to atomoxetine, severe allergies to more than 1 class of medications, or multiple adverse drug reactions.
- •Patients who have received treatment within the past 30 days with a drug that has not received regulatory approval for any indication at the time the informed consent document is obtained.
研究组 & 干预措施
Atomoxetine
Experimental
干预措施: Atomoxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks
时间窗: Baseline, up to 10 weeks
CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.
次要结局
- The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks(10 weeks)
- Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks(Baseline, up to 10 weeks)
- Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks(Baseline, up to 10 weeks)
- Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks(Baseline, up to 10 weeks)
- Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks(Baseline, up to 10 weeks)
- The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks(10 weeks)
- Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks(Baseline, up to 10 weeks)
- Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks(Up to 10 weeks)
- Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks(Baseline, up to 10 weeks)
- Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks(Baseline, up to 10 weeks)
研究者
研究点 (1)
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