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, Andre 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.
AJOB neuroscience
June 16, 2025
Owen Thomas, Francisca Silva
Laypeople morally disapprove of hypothetical love drugs more than psychological therapy because they perceive the resulting feelings as inauthentic. Authenticity and naturalness drive these moral judgments. However, the line between organic and artificial experiences is blurry; emotions from love drugs could be meaningful and authentic if they foster lasting positive change and align with personal values. Natural feelings are also shaped by external stimuli affecting brain function. Where love drugs support transformative experiences, they should not be viewed as immoral.