title: Psychotropic drugs and paediatrics: a critical need for more clinical trials.
abstract: Many children in the USA are prescribed psychotropic drugs that have not been fully investigated in paediatric clinical trials. The common practice of prescribing psychotropic drugs off-label poses unknown and potentially serious short- and long-term consequences for these children. This paper briefly reviews the factors associated with the lack of paediatric clinical trials. We advocate a shift toward increasing paediatric trials with psychotropic drugs through a combination of adequate safety controls, additional reimbursement/compensation, a more organised and large-scale effort to collate results and outcomes across researchers and studies and additional public education about the importance of this research. In addition, we encourage the re-examination of the ethical standards for children's participation in phase 1 clinical trials as well as argue for longitudinal developmental studies on children who are prescribed off-label psychotropic drugs.
authors: Department Psychology, The Ohio State University, Columbus, OH 43203, USA. tishler.1@osu.edu
authors: Carl L
authors: CL
authors: Tishler
authors: Natalie S
authors: NS
authors: Reiss
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D010372:Pediatrics / Q000941:ethics* / Q000379:methods*; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011619:Psychotropic Drugs