The purpose of the contract is to 1) establish qualified clinical research units that, by building of existing research resources at the host institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies on the safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and 2) fund selected research projects of particular public health significance, in particular in the area of autism and other pervasive developmental disorders, to be conducted at these units. The units, will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including (but not limited to): dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. To establish research units of where clinical studies on the safety, efficacy, pharmacokinetics and pharmacodynamics of psychotropic medications can be investigated in children and adolescents, in general, and in patients suffering from autism and other pervasive developmental disorders in particular. To conduct a minimum of 1 clinical trial of the efficacy of a psychotropic medication in children and/or adolescents with mood disorders. To spur the conduct of other clinical trials and studies in pediatric psychopharmacology to be funded through mechanisms other than this contract and in collaboration with other RUPPs (i.e., investigator-initiated grants from federal agencies, private foundations, and pharmaceutical companies).
| Daviss, W Burleson; Perel, James M; Brent, David A et al. (2006) Acute antidepressant response and plasma levels of bupropion and metabolites in a pediatric-aged sample: an exploratory study. Ther Drug Monit 28:190-8 |
| Daviss, W Burleson; Perel, James M; Rudolph, George R et al. (2005) Steady-state pharmacokinetics of bupropion SR in juvenile patients. J Am Acad Child Adolesc Psychiatry 44:349-57 |
