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Steffen Thirstrup

3 papers in the library · 39 citations · publishing 2023-2025

Papers

Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects.

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.

DOI: 10.1016/j.nsa.2024.103938 Full text Psychedelic-assisted therapy Psychedelic treatment Psychedelic therapeutics Psychedelics for therapy +19

Applying the EU Regulatory Framework to Determine the Benefit-Risk Profile of Psychedelics.

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.

DOI: 10.1021/acsptsci.5c00456 Full text Challenges Clinical trials Marketing authorization Mental-health disorders +2