Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Change from Baseline Heart Rate at 6 months
研究概览
简要总结
This study investigates the psychophysiological responses to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three months: 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their omega-3/placebo condition clinical diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between ages 7 and 16 years
- •Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
- •Subjects with willingness to participate in a randomized, double-blind controlled trial
- •Subjects with complete written, informed parental consent and child assent
- •Subjects with IQ of 70 or more
排除标准
- •Subjects who have IQ in the below 70
- •Subjects who are younger than 7 years old or older than 16 years old
- •Those without written parental consent
- •Those with brain pathology such as serious head injury, epilepsy, etc.
结局指标
主要结局
Change from Baseline Heart Rate at 6 months
时间窗: 7 minutes each at 0 months and 6 months
For Trier Social Stress Task
Change from Baseline Skin Conductance Response at 6 months
时间窗: 4 minutes each at 0 months and 6 months
For loud sound
次要结局
未报告次要终点
研究者
Jean Liu
Assistant Professor
Yale-NUS College