Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Percent Errors in Visual Go/NoGo Task
研究概览
简要总结
The purpose of this research study is to study a device called an electroencephalograph (EEG) in the diagnosis of treatment of attention deficit hyperactivity disorder (ADHD) in adults. People with ADHD have symptoms such as difficulty sustaining attention, organizing, and managing impulsivity. They can have trouble in school, at work, and at home. Subjects with ADHD who participate in this study will be given a once daily stimulant medication called osmotic release methylphenidate (Concerta) for 6 weeks, and have EEG testing done before and after the treatment period. Subjects will perform a computer based cognitive task during EEG testing. The U.S. Food and Drug Administration has approved osmotic release methylphenidate (Concerta) for the treatment of ADHD in adults and children. Similar procedures, without medication, will be performed with a sample of healthy adults without ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female outpatients, aged 18-55 years
- •Subjects meeting full criteria for the diagnosis of DSM-IV (Diagnostic and Statistical Manual, Version 4) Attention Deficit Hyperactivity Disorder (ADHD)
- •Absence of pharmacological treatment for ADHD for at least one week.
- •Right handedness
排除标准
- •Any other current psychiatric or medical condition determined to be clinically significant.
- •Current use of psychotropics or any medication with clinically significant CNS (Central Nervous System) effects.
- •Mental retardation (IQ < 80).
- •Significant sensory deficits such as deafness or blindness.
- •Individuals with a history of substance dependence or abuse within the past 6 months.
- •Pregnant or nursing females.
- •Subjects with pre-existing structural cardiac abnormalities.
- •Clinically significant abnormal laboratory values, electrocardiogram or blood pressure reading
- •Healthy Control Subjects
- •Inclusion Criteria:
- •Males and females, aged 18-55 years
- •Subjects who do not meet full criteria for the diagnosis of DSM-IV Attention Deficit Hyperactivity Disorder (ADHD), as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
- •Right handedness
- •Exclusion Criteria:
- •Any current psychiatric or medical condition determined to be clinically significant.
- •Current use of psychotropics or any medication with clinically significant CNS effects.
- •Mental retardation (IQ < 80).
- •Significant sensory deficits such as deafness or blindness.
研究组 & 干预措施
Concerta
Open-Label Concerta (Osmotic Release Methylphenidate)
干预措施: Osmotic Release Methylphenidate (Drug)
结局指标
主要结局
Percent Errors in Visual Go/NoGo Task
时间窗: Single Point (Baseline)
The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group.
Adult ADHD Investigator Symptom Rating Scale (AISRS)
时间窗: Baseline and 6 weeks
An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.
次要结局
未报告次要终点
研究者
Joseph Biederman, MD
Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital