Toward a framework for psychedelic clinical trials in adolescents

Psychedelic therapies show promise for adult mental health conditions, and there is growing interest in testing them in adolescents, who often experience these disorders earlier in life. Regulatory agencies are expected to require trials in younger populations after adult approvals. This paper outlines key considerations for designing and conducting such trials, including safeguards and best practices tailored to adolescents. It builds on adult trial methods and emphasizes increased psychological support and rigorous oversight. The goal is to ensure future adolescent trials are safe, ethical, and meet high scientific and regulatory standards, fostering patient-focused dialogue.

Study at a glance

Abstract

Recent clinical trials conducted by both industry and academic institutions have demonstrated the therapeutic potential of psychedelics for a variety of mental health conditions in adults. Considering the neurodevelopmental aspects of many of these disorders and the widespread occurrence of these conditions among younger individuals, there is increasing interest in exploring the potential for psychedelic therapies in the adolescent population. Regulatory agencies globally are also expected to require clinical trials in younger populations once such products are approved for adults. This paper details some key considerations for the design and conduct of such trials along with safeguards and best practices tailored to adolescents, building upon established methodologies from adult trials and emphasizing the importance of increased psychological support and rigorous trial oversight. Our goal is to provide a framework that ensures that future clinical trials involving the adolescent population are performed safely, ethically, and in accordance with the highest scientific and regulatory requirements, and to foster a patient-centric dialog within the regulatory and scientific community.