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.
