Hopkins Researchers Study Drugs to Help "Therapeutic Orphans"

According to NIMH, some 8 million children deal with behavioral and emotional problems each year. While medication is often part of treatment, up to 80 percent of the drugs marketed today are not approved for use in children or adolescents. The Food and Drug Administration requires that all new drugs be tested in every population in which they are to be used; however, many obstacles hamper pharmacologic research in children. Besides overcoming the ethical and methodological challenges, there are few qualified investigators who exhibit the required expertise in pharmacology, child psychiatry and pediatrics.

"Children have been therapeutic orphans for many years," says Mark A. Riddle, M.D., director of the Division of Child and Adolescent Psychiatry at Hopkins and principal investigator. "This is especially true in pediatric psychopharmacology; there are sparse data on the safety and efficacy of psychotropic medications in kids. The RUPPs will make it possible for this to begin to change."

Both RUPPs will perform clinical trials and research projects in many areas, including the effects of psychiatric drugs on children's behavior, development, and cognition, the safest dose ranges, and the most effective and safe dose regimens. The RUPP network also is collaborating with the existing network of Pediatric Pharmacology Research Units.

The facilities of the Johns Hopkins RUPP include the NIH-funded Pediatric Clinical Research Center, with fully staffed inpatient and outpatient areas; laboratories and expertise in designing pharmacokinetic studies, provided by the Division of Clinical Pharmacology; and relationships with many pediatric and child psychiatry practices throughout the Baltimore area.

Studies planned or in progress at the Children's Center include research on children and adolescents with obsessive compulsive disorder, major depressive disorder, attention deficit hyperactivity disorder, and anxiety disorders, including social phobia and separation anxiety.

"My hope is that some day, pediatric psychopharmacology will be as advanced as pediatric cancer chemotherapy," says Riddle. "There will be multisite studies that compare new agents to standard treatments, making information available to help treatment decisions. Our patients deserve nothing less than this."

In addition to the NIH funds, the division also received a $200,000 supplemental grant from Solvay Pharmaceuticals.

The New York State Psychiatric Institute also received a contract.

The Johns Hopkins Children's Center is the children's hospital of The Johns Hopkins Medical Institutions. Maryland's most comprehensive acute-care hospital for children, the center, with its 177-bed hospital and more than 40 divisions and services, treats some 8,000 inpatients annually, with more than 90,000 outpatient visits.