Measuring Glutamate and GABA Brain Levels in Adults With Attention Deficit Hyperactivity Disorder (ADHD) Using Magnetic Resonance Spectroscopy (MRS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Glu and GABA levels measured by MRS in ACC brain area
研究概览
简要总结
Background:
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurobiological brain disorders. Diagnosis of ADHD in adults is complex and subjective. Recent studies give further support for the involvement of glutamatergic and GABAergic neurotransmitters in the pathophysiology of ADHD. Studies show that glutamate (Glu) and GABA change according to stimulant treatment. Measuring modulations in the anterior cingulate cortex (ACC) of Glu and GABA may help to explore the pathophysiology of ADHD and give a diagnostic biomarker tool for ADHD in adults.
Aim:
To characterize Glu and GABA levels in the ACC, by using the proton Magnetic Resonance Spectroscopy ([1H]MRS) system in adults with ADHD compared to healthy control subjects (HCS), before and after stimulant treatment, and to correlate between Glu and GABA levels and clinical symptoms.
Method:
ADHD adults ages 18-40 years (N= 35), and HCS (N= 25), will fill out a DSMV and ASRS questionnaire.
Spectroscopic analyses will be done using 1H MRS (3T) in ADHD adults, before and after stimulant treatment (Methylphenidate /Mixed Amphetamine salts) in an open-label fashion as compared to HCS. Proton spectra will be acquired from the ACC.
详细描述
Hypothesis:
- We hypothesize that brain Glu and GABA levels and/or their ratio involved in ADHD pathology
- Glu and GABA levels and/or their ratio will be affected by medical treatment in ADHD group
- Alteration of Glu and GABA and/or their ratios, before and after treatment, will correlate with clinical response to treatment
Primary Objectives:
To characterize changes in Glu and GABA levels in the ACC of adults with ADHD compared to the healthy subjects To characterize Glu and GABA levels in the ACC of adults with ADHD before and 1.5 hrs. after stimulant treatment using 1H MRS system.
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Giving informed written consent to participate on a voluntary basis.
- •For the healthy control group:
- •Men and women aged 18-40 years, who did not report ADHD or any other chronic or psychiatric illness or medical conditions (at most two symptoms of inattention and/or hyperactivity/impulsivity).
- •For the ADHD group patients:
- •Men and women aged 18-40 years, who have a diagnosis of ADHD, according to DSM V criteria by a Neurologist.
- •Have a valid prescription for Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin) for ADHD
- •Withhold medication 72h prior to MRS scan.
排除标准
- •Exclusion criteria identical for patients and control group:
- •Subjects with metallic devices that precludemagnetic resonance imaging or any silver part that is not MRI compliant
- •Current presence of any other DSM V psychiatric disorder
- •Significant medical or neurological illness affecting brain function
- •Subjects with any clinically significant or unstable medical conditions
- •Use of any psychotropic medication, other than stimulants, in the previous 3 months
- •Pregnant women
- •History of brain MRI
- •A patient who does not agree that the scan will be decoded by a radiologist
- •A patient who does not agree that in case of an abnormal finding, the imaging results will be forwarded to the attending physician for further clarification
- •Understanding and/or language problems
结局指标
主要结局
Glu and GABA levels measured by MRS in ACC brain area
时间窗: 72 hours without stimulant
Differences in levels of Glu and GABA in ADHD patients compared to healthy volunteers
Glu and GABA levels measured by MRS in ACC brain area before and after medical treatment
时间窗: 90 minutes after stimulant
Differences in levels of Glu and GABA measured before and after medical treatment.
次要结局
- Correlation of Glu and GABA levels with clinical symptoms before and after stimulants(210 minutes after stimulant)