Article Text

Download PDFPDF
Psychotropic drugs and paediatrics: a critical need for more clinical trials
  1. Carl L Tishler1,
  2. Natalie S Reiss2
  1. 1Department Psychology, The Ohio State University, OH, USA
  2. 2The Case Western Reserve University Counseling Services, Cleveland, OH, USA
  1. Correspondence to Dr Carl L Tishler, Department Psychology, The Ohio State University, 1776 East Broad Street, Columbus, OH 43203, USA; tishler.1{at}


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.

  • Behavioural research
  • philosophical ethics
  • psychotherapy
  • suicide/assisted suicide

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


  • Funding This work was supported, in part, by funds designated to the Ohio State University Hospitals East projects.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Other content recommended for you