Neurosci Appl
January 11, 2024
Drummond E-Wen McCulloch, Matthias E. Liechti, Kim PC. Kuypers et al.
10 citations
Psychedelic drugs like psilocybin and LSD are being tested in clinical trials for psychiatric and neurological conditions, with phase 2 studies showing particular promise for depression. At a 2023 European College of Neuropsychopharmacology meeting, experts identified key knowledge gaps that need addressing for successful medical implementation. These include understanding how these drugs work in the body (pharmacokinetics and pharmacodynamics), comparing different psychedelics, exploring the link between the duration of subjective effects and therapeutic outcomes, studying polypharmacology, and assessing the role of psychological support. The article also presents perspectives from the European Medicines Agency and Health Technology Assessors on what is most needed for medical adoption in Europe.
Neuroscience applied..
January 1, 2025
Francisca Silva, Florence Butlen-Ducuing, Lorenzo Guizzaro et al.
4 citations
A review of eight completed phase 2 or 1/2 clinical trials of psychedelics for depression found that the trials tested psilocybin, LSD, ayahuasca, and DMT in patients with major depressive disorder or treatment-resistant depression. The analysis examined methodological patterns in trial design, population, interventions, outcome measures, and safety assessments, comparing them with regulatory considerations on unblinding, expectancy, choice of comparator, treatment frameworks, subjective experience characterization, and adverse event specification. The authors suggest that larger studies are needed to investigate long-term efficacy, safety, and inter-individual differences. Early dialogue with regulators may help balance trial complexities with regulatory requirements for medicines development.
ACS pharmacology & translational science
August 8, 2025
Kate Browne, Ewa Bałkowiec-iskra, André Elferink et al.
1 citation
Marketing authorization applications for psychedelics in the European Union must meet the same regulatory and evidentiary standards as all other medicinal products. The European Medicines Agency identifies key knowledge gaps that complicate pivotal trial design and benefit-risk assessment, including functional unblinding, expectancy and nocebo effects, and the need to align trial populations with the intended therapeutic indication. Development programs should characterize dose-response relationships and the link between subjective experience and therapeutic response. Decisions about incorporating psychological support or psychotherapy affect trial design and conditions of use. Safety characterization requires adequately powered trials, appropriate controls, risk mitigation strategies, continuous monitoring, and ethical consideration.