Recent advances in psychedelic research have demonstrated promising therapeutic potential across a range of mental health conditions in adults. In this open-access review, Worldwide Clinical Trials experts examine what it will take to responsibly extend this research into adolescent populations.
The article outlines a practical framework for designing and conducting psychedelic clinical trials in individuals under 18, addressing key challenges such as neurodevelopmental considerations, ethical consent and assent, regulatory expectations, and heightened safety requirements. It highlights the importance of conservative dosing, robust oversight, tailored outcome measures, and enhanced psychological support before, during, and after treatment.
With mental health conditions affecting approximately 1 in 7 adolescents globally—and limited effective treatment options for many—this work provides timely guidance to help sponsors and researchers navigate a complex but critical next frontier in clinical development.
This article was originally published in Child and Adolescent Psychiatry and Mental Health (2026) and is distributed under the Creative Commons Attribution 4.0 International License.
Read the Version of Record here.
