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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}osu.edu

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.

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Footnotes

  • 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.

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