Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Conners' Adult Attention Rating Scale (CAARS)
研究概览
简要总结
The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD) and attention deficit disorder (ADD).
详细描述
No medications have been investigated to improve attention and executive functions in patients with Huntington's disease, despite the evidence that these cognitive domains can be abnormal even before motor symptom onset. Because cognitive symptoms are highly associated with functional disability, treatments aimed at improving cognitive functions would be of significant benefit to patients in the early stages of the disease. Atomoxetine is the ideal choice for such a trial. It has proven efficacy in adults with attention deficit hyperactivity disorder (ADHD) and it selectively targets norepinephrine and dopamine in the prefrontal cortex rather than in subcortical areas. This selectivity is an advantage for patients with HD, because motor side effects are less likely to be facilitated than with a psychostimulant. The present study is a feasibility study in which we propose to administer either 80 milligram (mg) atomoxetine for 4 weeks or placebo to 20 patients with early HD who also complain of mild cognitive symptoms. The groups will then crossover to the other condition (atomoxetine or placebo). Participants will be assessed on measures of ADHD symptoms and a sensitive battery of neuropsychological tests. Based on the shared neural circuitry in ADHD and HD, and the demonstrated effectiveness of atomoxetine on attention in adults with ADHD, improved performance on cognitive tests of attention and executive functions and on subjects' report of ADHD symptoms are expected in the atomoxetine treatment phase. No changes in motor status are predicted during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Huntington's disease (HD) diagnosis
- •Age 18 to 65
- •Must have mild HD
- •Must have complaints of poor attention
排除标准
- •Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
- •Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
- •Current use of a monoamine oxidase inhibitor (MAOI) medication
- •Pregnancy
- •Uncontrolled hypertension
- •Tachycardia
- •Cardiovascular or cerebrovascular disease
- •History of a loss of consciousness for greater than (or equal to) 5 minutes
- •Having any neurological disorder or insult other than Huntington disease
研究组 & 干预措施
40 milligram twice a day atomoxetine
Participants received 40 milligram twice a day atomoxetine for 4 weeks.
干预措施: atomoxetine (Drug)
Twice a day matching placebo
Participants received twice a day matching placebo for 4 weeks.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Conners' Adult Attention Rating Scale (CAARS)
时间窗: There are two time points for this measure: baseline and after 4 weeks of treatment
The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm.
Attention Composite Score
时间窗: There are two time points for this measure: baseline and after 4 weeks of treatment
The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm.
Executive Composite Score
时间窗: There are two time points for this measure: baseline and after 4 weeks of treatment
The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm.
次要结局
- Symptom Checklist-90-Revised (SCL-90-R)(There are two time points for this measure: baseline and after 4 weeks of treatment)
- Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score(There are two time points for this measure: baseline and after 4 weeks of treatment)
研究者
Beglinger, Leigh J
Associate Professor
University of Iowa