Treatment of ADHD in Pediatric Patients with Epilepsy

描述（由申请人提供）：癫痫非常普遍，并与精神疾病的风险增加有关。慢性复发性癫痫患者被排除在大多数建立儿科精神病学标准治疗的药理学试验之外。寻找安全有效的治疗小儿癫痫患者精神障碍的方法具有紧迫的公共卫生重要性。本次指导患者导向研究发展奖（K23）的目的是让候选人成为面对癫痫的儿童和青少年精神疾病的精神药理学治疗的独立临床研究人员。该提案的重点是患有多动症和癫痫的患者。该项目将在波士顿儿童医院（CHB）进行，该医院为大量癫痫患者提供服务。具有儿科精神药理学临床试验专业知识的Joseph Biederman医学博士将担任主要导师。CHB精神病学主席William R. Beardslee医学博士将担任发起人。Blaise Bourgeois医学博士是CHB癫痫和临床神经生理学部门的主席，他是主要的癫痫顾问。研究计划：目的是：1)开展一项随机安慰剂对照交叉试验，研究哌醋甲酯缓释片（Concerta）在小儿ADHD合并癫痫患者中的应用；2)建立保证癫痫患儿精神药理学临床试验安全的方法。职业发展规划：培训将强调在青少年癫痫合并精神疾病患者中进行随机对照临床试验的必要技能，并探索其精神病理风险增加的神经生物学机制。在干预研究设计、统计学、发展精神病理学、精神病理学评估方法和治疗反应方面的教学工作将补充项目顾问的监督。该候选人的长期目标是开发和评估患有共病精神疾病和癫痫的儿童的治疗方法，以及调查这些疾病治疗的风险和反应的神经生物学相关性。

DESCRIPTION (provided by applicant): Epilepsy is highly prevalent and associated with increased risk for psychiatric disorders. Patients with chronic recurrent seizures are excluded from most pharmacological trials establishing standard treatments in pediatric psychiatry. Finding safe and effective treatments for psychiatric disorders in pediatric patients with epilepsy is of pressing public health importance. The purpose of this Mentored Patient-Oriented Research Development Award (K23) is for the candidate to become an independent clinical researcher in the psychopharmacologic treatment of psychiatric disorders in children and adolescents facing epilepsy. The proposal focuses on patients with comorbid ADHD and epilepsy. The project will be conducted at Children's Hospital Boston (CHB), which serves a large population of patients with epilepsy. Joseph Biederman, MD, with expertise in clinical trials in pediatric psychopharmacology will serve as the primary mentor. William R. Beardslee, MD, Chairman of Psychiatry at CHB will serve as the sponsor. Blaise Bourgeois, MD, Chairman of the Division of Epilepsy and Clinical Neurophysiology at CHB is the principal epilepsy consultant. Research plan: The aims are: 1) To perform a randomized placcbo controlled crossover trial of extended release methylphenidate (Concerta) in pediatric patients with comorbid ADHD and epilepsy; 2) To establish methods of assuring the safety of children with epilepsy in psychopharmacological clinical trials. Career development plan: The training will emphasize skills necessary for conducting randomized controlled clinical trials in youth with epilepsy comorbid with psychiatric disorders and to explore the neurobiological mechanisms underlying their increased risk for psychopathology. Didactic work in intervention research design, statistics, developmental psychopathology, and assessment methodologies for psychopathology and treatment response will complement supervision by the program consultants. The long-term goals of the candidate are to develop and evaluate treatments for children with comorbid psychiatric disorders and epilepsy as well as to investigate neurobiological correlates of the risk and response to treatment of these disorders.