NCT00510276已完成4 期
A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint
研究概览
简要总结
This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least moderate severity
- •male or female 18 to 30 years of age
- •must be able to swallow capsules
- •must be able to communicate effectively in English
- •must not have cognitive impairment
- •be reliable to keep appointments for clinic visits and all related tests
排除标准
- •patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis
- •females who are pregnant or breastfeeding
- •patients with dementia or traumatic brain injury
- •patients with a history of severe allergy to atomoxetine
- •have untreated hypertension or thyroid problem
- •have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases
研究组 & 干预措施
Atomoxetine
Experimental
干预措施: Atomoxetine hydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint
时间窗: Baseline, Week 12
CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.
次要结局
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)(Baseline, 12 weeks)
- Responders by Baseline Smoking Status(12 weeks)
- Strong Responders by Baseline Smoking Status(12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score(Baseline, 12 weeks)
- Endpoint Scores in Patient Global Impression - Improvement (PGI-I)(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)(Baseline, 12 weeks)
- Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)(Baseline, 12 weeks)
- Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section(Baseline, 12 weeks)
- Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section(Baseline, 12 weeks)
研究者
研究点 (1)
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