The recent controversy concerning the relationship between antidepressant medication and suicidal ideation and behavior has highlighted the need for better methods for standardized and systematic monitoring of adverse events associated with the use of such agents.
The aim of this project is to develop better methods to systematically screen for and assess adverse events associated with the use of antidepressant medications with children and adolescents, including suicidal events and symptoms/behaviors thought to portend increased suicide risk. The methods to be developed are necessary for a planned R01 study to (1) evaluate the risks of antidepressant medications and (2) examine the impact of introducing a standardized safety monitoring procedure on clinical practice. Two methods will be developed: (1) A computerized screening instrument for adverse events experienced by children and adolescents who take SSRI's and other anti-depressant medications. The this instrument will: (a) have parent and youth versions (b) use sound technology so that the computer """"""""reads"""""""" the questions, allowing use with those of limited reading ability, (c) yield an instant report that will indicate areas of possible concern and (d) be feasible to include in psychopharmacological research trials and busy community settings (2) A standard glossary of adverse events and materials (including videotapes) which can be used to systematically classify specific adverse events thought to be associated with treatment of depressive illness. The glossary will help improve the classification of adverse event reports The performance characteristics -- test-retest reliability, validity, feasibility, acceptability to clinicians and patients (and parents) - of the computerized AE screening instrument will be evaluated in 80 child and adolescent/parent pairs. Data from the study will be used to refine the screen and will serve as a foundation for the R01 application, which will be prepared during the second year of the project. A second long term goal of the research is to develop a user friendly, psychometrically sound assessment method that might be used in typical community settings to better monitor the safety of antidepressant medications with pediatric patients. ? ? ?
