NCT01351272已完成3 期
Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Brain Activation
研究概览
简要总结
In this study the investigators will measure the functional brain activity of adult Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic effect of MPH treatment on cognitive functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only participants will be included who (1) fulfil the diagnostic criteria defined in guidelines for the diagnosis of ADHD in childhood and adulthood and who (2) would be treated with MPH also for clinical indications outside the study.
- •Provision of written informed consent
- •A diagnosis of a ADHD (314.xx) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- •Females and males aged 18-50 years
- •Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- •Able to understand and comply with the requirements of the study
- •Right-handed according Edinburgh Handedness Inventory (Oldfield, 1971)
- •German as first language
- •Caucasian ethnicity
排除标准
- •Pregnancy or lactation; women capable of childbearing are required to use a reliable method (Pearl-index < 1%) of contraception (e.g. hormonal treatment, intrauterine device, vasoligation in the partner, sexual abstinent)
- •Any current DSM-IV Axis I disorder not defined in the inclusion criteria requiring current additional treatment
- •Motoric tics, siblings with tics or positive family history or diagnosis of a Tourette syndrome
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •Known intolerance or lack of response to methylphenidate, as judged by the investigator
- •Present pre-treatment with methylphenidate (within the last three month prior to study treatment)
- •Intake of MAO-inhibitors within the last 14 days prior to study treatment
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •Unstable or inadequately treated medical illness (e.g. Congestive Heart Failure / CHF, angina pectoris, hypertension, narrow angle glaucoma, hyperthyroidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator.
- •An absolute neutrophil count (ANC) of minor 1.5 x 10 exp 9 per litre
- •Involvement in the planning and conduct of the study
- •Previous enrolment or randomisation of treatment in the present study
- •Participation in another drug trial within 4 weeks prior to enrolment into this study
- •Moderate, severe, or profound mental retardation
- •Heart pacemakers, cochlea implants, other metal parts in the head outside the mouth
研究组 & 干预措施
methylphenidate, non-retard
Experimental
干预措施: Methylphenidate, non-retard (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Brain Activation
时间窗: 6 weeks
Functional brain activity in right Superior Frontal Gyrus (SFG) during the working memory task post treatment as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests.
次要结局
- ADHD Core Symptoms: Measured by Conners Adult ADHD Rating Scales (CAARS), Inattention Scale(6 weeks)
- Neuropsychology(6 weeks)
研究者
Martin Herrmann
Principal Investigator
Wuerzburg University Hospital
研究点 (1)
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