Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD): a Biomarker to Predict Treatment Response
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
- Diffusion imaging-based measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).
研究概览
简要总结
This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).
详细描述
There is a pressing need in psychiatry to offer more individualised treatments, and to improve outcomes from clinical trials. This 'individualised medicine' approach requires the development of biomarkers of treatment response.
60 adults with ADHD are recruited from the Adult ADHD Clinic at the Maudsley Hospital, London, United Kingdom.
The study is developed over three sessions, two at baseline (DAY 1 and DAY 2) and one after two months of treatment (follow-up).
The first two sessions are conceived as a single-blind non-randomised placebo-controlled cross-over experiment. The first 30 participants enrolled in the study receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 before the behavioural assessment and magnetic resonance imaging (MRI) scan. The behavioural assessment and the functional MRI measurements are repeated two days after (DAY 2), under a clinically effective dose (20 mgs) of short-acting methylphenidate (MPH).
The order of the tablets is reverted for the remaining 30 participants to balance any potential expectation and practice effect between the two conditions. Placebo and medication are over-encapsulated with the same red opaque capsules by the pharmacy team. Also, the protocol followed during the two sessions is absolutely identical in respect of timing and tests administered in order to keep the participants blind to the drug condition (medication or placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The first part of the study (DAY 1 and DAY 2) is conceived as a single-blind placebo-controlled cross-over experiment. Participants are blind to the order of the tablets (placebo and MPH). After the two scanning sessions, all 60 participants are started on a long-acting formulation of MPH used routinely at the Adult ADHD Clinic (open trial phase).
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •aged 18-45 years old
- •intelligent quotient (IQ) > 70 (as measured by WASI)
- •diagnosis of ADHD confirmed through clinical assessment (Adult ADHD Clinic)
- •non-medicated (stimulant medication-naive or not taking stimulant medication for at least 4 weeks)
排除标准
- •no other brain disorders other than ADHD
- •no condition precluding MRI scanning (e.g., metallic implants, claustrophobia)
研究组 & 干预措施
Placebo, MPH
Dose order: placebo, methylphenidate (MPH)
Participants receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 and a clinically effective dose of short-acting MPH (20 mgs) on DAY 2.
干预措施: MPH (Drug)
MPH, Placebo
Dose order: methylphenidate (MPH), placebo
Participants receive a clinically effective dose of short-acting MPH (20 mgs) on DAY 1 and a placebo tablet (ascorbic acid 50 mgs) on DAY 2.
干预措施: MPH (Drug)
结局指标
主要结局
Diffusion imaging-based measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).
时间窗: In the month 2-3 following the last scan.
Diffusion based measurements include specific measures of anatomical connectivity of pathways originating in the frontal lobes, such as the fronto-striatal pathways and the superior longitudinal fasciculus. According to previously published criteria, treatment response is defined as a symptomatic improvement of at least 30%, as measured by participants' performance on adult ADHD rating scale at follow-up as compared to baseline.
次要结局
- Functional connectivity measurements as statistically significant predictors of treatment response as defined by a data-driven approach.(In the month 8-9 following the last scan.)
- Functional connectivity measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).(In the month 4-5 following the last scan.)
- Diffusion imaging-based measurements as statistically significant predictors of treatment response defined by a data-driven approach.(In the month 6-7 following the last scan.)