A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder: With a Secondary Examination of Impact of Treatment on Family Functioning
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
研究概览
简要总结
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.
详细描述
The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).
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
- Triple (Participant, 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
- •Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID).
- •Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or greater Visit 2 and
- •Adult Men and Women age 18 years or older at time informed consent is obtained.
- •Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study.
- •Must have one or more children 6-17 years of age living the home as the primary residence.
排除标准
- •Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder.
- •Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder.
- •Taking psychotropic medications on a regular basis.
- •Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial.
- •Previously taken an adequate trial of atomoxetine.
研究组 & 干预措施
Placebo
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.
干预措施: Placebo (Drug)
Atomoxetine
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
干预措施: Atomoxetine Hydrochloride (Drug)
结局指标
主要结局
Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
时间窗: Baseline, 24 weeks
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
时间窗: Baseline, 12 weeks
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
次要结局
- Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant(Baseline, 8 weeks)
- Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant(Baseline, 24 weeks)
- Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other(Baseline, 8 weeks)
- Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other(Baseline, 24 weeks)
- Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant(Baseline, 8 weeks)
- Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant(Baseline, 24 weeks)
- Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other(Baseline, 8 weeks)
- Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other(Baseline, 24 weeks)
- Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress(Baseline, 8 weeks)
- Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains(Baseline, 8 weeks)
- Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains(Baseline, 8 weeks)
- Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress(Baseline, 24 weeks)
- Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains(Baseline, 24 weeks)
- Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains(Baseline, 24 weeks)
- Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form(Baseline, 12 weeks)
- Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form(Baseline, 24 weeks)
- Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form(Baseline, 12 Weeks)
- Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form(Baseline, 24 Weeks)
- Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form(Baseline, 24 weeks)
- Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags(Baseline, 24 weeks)
- Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale(Baseline, 8 weeks)
- Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale(Baseline, 24 weeks)
- Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores(Baseline, 12 weeks, 24 weeks)
- Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)(Baseline, 8 weeks, 24 weeks)
- Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)(Baseline 12 weeks, 24 weeks)
- Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)(Baseline, 12 weeks, 24 weeks)
- Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores(Baseline, 1 week)
- Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores(Baseline, 2 weeks)
- Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo(Baseline, after 2-week titration period beginning at Week 24)