Neuroimaging of Diet and Medication in the Treatment of ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ADHD Rating Scale IV
研究概览
简要总结
Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.
详细描述
The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks relative to the Ruse diet group. In addition children will undergo functional magnetic resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC) during attention tasks. The children will also perform will look at pictures of appealing and unappealing food and rate whether they would like to eat it or not. This task is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is whether children on the restricted diet will show changes in activity and connectivity of areas (DLPFC, ACC, VS) relative to those on the Ruse diet.
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
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 9-12 years
- •Meets criteria for Attention Deficit Hyperactivity Disorder
- •Parent must agree to use Study Diet Manual
排除标准
- •Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management
- •Not currently on any pharmacological agent other than medication for ADHD
研究组 & 干预措施
Restricted Diet
Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
干预措施: Restricted Diet (Dietary Supplement)
Ruse Diet
Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.
干预措施: Ruse Diet (Dietary Supplement)
结局指标
主要结局
ADHD Rating Scale IV
时间窗: 5 weeks
The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.
次要结局
未报告次要终点
研究者
Steven Pliszka
Professor and Chief, Division of Child and Adolescent Psychiatry
The University of Texas Health Science Center at San Antonio