A review of psychedelics trials completed in depression, informed by European regulatory perspectives.
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.