Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ADHD Clinical Global Impressions Scale - Improvement (CGI-I)
研究概览
简要总结
This is a 6-month trial in adults to find out if certain neuromarkers can predict individual treatment response to stimulant medications for Attention Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-45, will complete an MRI scan at MIT prior to beginning medication for ADHD as determined by a treating clinician outside the context of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Male and female adults ages 18-55
- •A diagnosis of DSM-V ADHD based on clinical assessment supported by the ADHD module of a structured diagnostic interview
- •Proficiency in English
- •Right-handed
排除标准
- •Any contraindication for the use of a stimulant medication
- •Investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild)
- •Any contraindications for MRI examination (metallic implants, such as pacemakers, surgical aneurysm clips, or known metal fragments in the body)
- •Women who are currently pregnant or breastfeeding, as confirmed by a urine pregnancy test
- •Clinically significant abnormal baseline laboratory values, including systolic and diastolic blood pressure parameters above 140 and 90, respectively and resting heart rate outside 60-100 bpm
结局指标
主要结局
ADHD Clinical Global Impressions Scale - Improvement (CGI-I)
时间窗: 6 months
The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
ADHD Clinical Global Impressions Scale - Severity (CGI-S)
时间窗: 6 months
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.
次要结局
- Connectomic Variation Prediction of Medicine Response(6 months)
研究者
Joseph Biederman, MD
Principal Investigator
Massachusetts General Hospital