Related Experiment Video

Updated: May 27, 2026

Event Related Potentials (ERPs) and other EEG Based Methods for Extracting Biomarkers of Brain Dysfunction: Examples from Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)
10:02

Event Related Potentials (ERPs) and other EEG Based Methods for Extracting Biomarkers of Brain Dysfunction: Examples from Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)

Published on: March 12, 2020

Psychotropic drugs and paediatrics: a critical need for more clinical trials

Carl L Tishler1, Natalie S Reiss

  • 1Department Psychology, The Ohio State University, Columbus, OH 43203, USA. tishler.1@osu.edu

Journal of Medical Ethics
|November 4, 2011
PubMed

Insights

Many children receive psychotropic drugs without sufficient pediatric testing, risking unknown consequences. Increased pediatric trials, ethical reviews, and public education are crucial for child safety and informed treatment.

Area of Science:

  • Pediatric pharmacology
  • Child psychology
  • Clinical trial ethics

Background:

  • Psychotropic medications are frequently prescribed to children in the USA.
  • Many of these prescriptions are off-label, meaning the drugs haven't been fully studied in pediatric populations.
  • This practice carries potential short- and long-term health risks for children.

Purpose of the Study:

  • To review factors contributing to the scarcity of pediatric clinical trials for psychotropic drugs.
  • To advocate for increased pediatric clinical trials of psychotropic medications.
  • To propose improvements in ethical standards and research methodologies for pediatric drug studies.

Main Methods:

  • Literature review of factors limiting pediatric psychotropic drug trials.
  • Analysis of current prescribing practices and their implications.
  • Discussion of ethical considerations for pediatric clinical trial participation.
  • Proposal of strategies to enhance pediatric drug research.

Main Results:

  • Identified a significant gap in pediatric clinical trial data for psychotropic drugs.
  • Highlighted the risks associated with off-label prescribing in children.
  • Outlined key areas for improvement in research conduct and oversight.
  • Emphasized the need for organized, large-scale research efforts.

Conclusions:

  • Urgent need for more robust pediatric clinical trials for psychotropic drugs.
  • Recommendations include enhanced safety controls, financial incentives, data collation, and public education.
  • Call for re-evaluation of ethical standards for pediatric phase 1 trials.
  • Advocacy for longitudinal studies on children using off-label psychotropic medications.

More Related Videos

Handwriting Analysis Indicates Spontaneous Dyskinesias in Neuroleptic Naïve Adolescents at High Risk for Psychosis05:52

Handwriting Analysis Indicates Spontaneous Dyskinesias in Neuroleptic Naïve Adolescents at High Risk for Psychosis

Published on: November 21, 2013

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development07:02

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development

Published on: February 11, 2019

Related Concept Videos

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight, compared...
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
Drug Therapy01:28

Drug Therapy

The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses a challenge in...
Psychosis: Goals of Pharmacotherapy01:26

Psychosis: Goals of Pharmacotherapy

Antipsychotic drugs are a crucial treatment method for acute and chronic psychoses, bipolar illness, and behavioral disorders. The selection of these drugs depends on several factors, including the state of the disease, clinical judgment, possible drug interactions, and the patient's sensitivity to adverse effects. In immediate scenarios, such as delirium and dementia, short-term treatment with low doses of high-potency typical or atypical agents can effectively manage symptom exacerbation. For...