Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stroop Test Interference T-score
研究概览
简要总结
Atomoxetine is the only medication that is currently approved by the FDA for the treatment of attention deficit hyperactivity disorder in adults. It has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (TBI), but it's effectiveness in this population has not been studied. There are a number of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. This study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with TBI
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of TBI
- •Moderate to severe TBI as indicated by Glasgow Coma Score (GCS) score of 12 or less; or Post Traumatic Amnesia (PTA) of seven days or more
- •at least one year post injury
- •between the ages of 18-65 (inclusive)
- •symptoms consistent with attentional dysfunction
- •consent to participate in study
排除标准
- •history of any conditions that would prohibit standard neuropsychological testing
- •non-English speaking (to the extent that would limit ability to complete study measures)
- •prior history of significant psychiatric illness requiring hospitalization
- •cardiovascular disease or risks including: dysrhythmias, angina, myocardial infarction, uncontrolled hypertension, valvular heart disease including mitral valve prolapse
- •use of any monoamine oxidase inhibitor or any other drug affecting brain monoamine concentrations
- •severe renal or hepatic impairment
- •pregnant or lactating
研究组 & 干预措施
Atomoxetine
40mg atomoxetine twice a day for 2 weeks
干预措施: atomoxetine (Drug)
placebo
Placebo twice a day for two weeks
干预措施: placebo (Drug)
结局指标
主要结局
Stroop Test Interference T-score
时间窗: Post treatment
The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.
CDR Power of Attention
时间窗: Post treatment
Cognitive Drug Research (CDR) Computerized Cognitive Assessment System \[19\] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations. Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,
Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score
时间窗: Post treatment
The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms ("never", "rarely", "sometimes", "often", and "very often"). A previous study of the ASRS found the self-report to be both valid (Cronbach's alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.
次要结局
- Neurobehavioral Functioning Inventory Depression Subscale(Post treatment)
研究者
Cynthia Harrison-Felix, PhD
Assistant Director of Research
Craig Hospital