ANTIPSYCHOTIC PHARMACOTHERAPY IN CHILDREN AND ADOLESCENTS: WHAT IS THE EVIDENCE FOR LONG-TERM SAFETY?

Robert L. Findling, M.D., 11100 Euclid Avenue, Cleveland, OH 44106-5000

Pharmacological treatment with antipsychotics in pediatric patients has moved from conventional agents toward "atypical" antipsychotics (clozapine, risperidone, olanzapine, and quetiapine), which have a reduced risk of extrapyramidal side effects (EPS). Open-label clinical studies have shown promise for use of these atypical compounds in a wide range of neuropsychiatric disorders in young patients. Well-designed, controlled studies of antipsychotics in children are few, and most have been completed within the past five years. Large, long-term studies are now available for risperidone, an antipsychotic with a high serotonergic to dopaminergic binding ratio in the central nervous system. More modest data are available on other newer antipsychotics. Conduct disorder is one of the most commonly diagnosed disorders in outpatient psychiatric clinics, frequently occurring with comorbid attention deficit/hyperactivity disorder (ADHD) or learning disorders. Treatment typically involves both pharmacological and behavioral therapies. This presentation will focus on data from an open-label, long-term extension study and the two newly completed long-term (one-year) international open-label studies of safety and efficacy of risperidone in children with severe conduct disorders with or without ADHD and subaverage intelligence. Available long-term safety data from studies with other atypical antipsychotics will also be discussed.