Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Adult Investigator Rating Scale
研究概览
简要总结
The primary aim of this study is to assess the predictability of treatment response to stimulants in adults with ADHD using functional magnetic resonance
This study will be a six-week, open-label study including adults ranging from age 18-55 with ADHD.
详细描述
Certain brain characteristics have been identified in individuals with persistent and remitted ADHD. We predict that neural functional connectivity; specifically decreases in connectivity between the posterior cingulated cortex and medial prefrontal cortex, as well as decreases in anticorrelations between the medial prefrontal cortex and dorsolateral prefrontal cortex, will predict greater response to stimulant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 or female adults ages 18-55 years
- •Right handed
- •A diagnosis current of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment
- •A score of > 20 on the Adult ADHD Investigator Symptom Report Scale (AISRS) or a CGI-Severity score of > 4 (moderate severity)
排除标准
- •A history of non-response or intolerance to stimulants at adequate doses as determined by the clinician
- •Pregnant or nursing females
- •Serious, unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease
- •Clinically unstable psychiatric conditions including suicidality, homocidality, bipolar disorder, psychosis, or lifetime history of a clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis
- •Tics or diagnosis of Tourette's syndrome
- •Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine
- •Current use of psychotropic medications
- •Current use of MAO Inhibitor or use within the past two weeks
- •Claustrophobia or an standard contraindications to MRI scanning (metal in body)
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent or grandchild
研究组 & 干预措施
OROS-MPH
OROS-MPH is administered in capsule form daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90mg/day.
干预措施: OROS-MPH (Drug)
结局指标
主要结局
Adult Investigator Rating Scale
时间窗: Baseline to 6 weeks
AISRS
次要结局
未报告次要终点
研究者
Thomas J. Spencer, MD
Principal Investigator
Massachusetts General Hospital