Toward a framework for psychedelic clinical trials in adolescents.

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.