The therapeutic potential of psychedelics: the European regulatory perspective
The Lancet February 11, 2023 Florence Butlen-Ducuing, Drummond E-Wen Mcculloch, Marion Haberkamp et al. 28 citations
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Florence Butlen-Ducuing
6 papers in the library · 60 citations · publishing 2023-2025
Papers
Psilocybin as Transformative Fast‐Acting Antidepressant: Pharmacological Properties and Molecular Mechanisms
Fundamental and Clinical Pharmacology July 16, 2025 Makiath Adebo, Marie Laure Bonnet, Ons Laouej et al. 10 citations
Psilocybin, a serotonergic psychedelic, is being reexamined for treating depression resistant to conventional antidepressants. Recent clinical trials suggest therapeutic potential, though its mechanisms remain unclear. Psilocybin's active metabolite, psilocin, primarily activates serotonin 5-HT2A receptors, which mediate its psychedelic effects, but its role in antidepressant effects is debated. Preclinical work explores neurotransmitter systems, neuroplasticity, and neural circuits involved. Understanding these mechanisms is crucial for validating psilocybin's use alongside SSRIs/SNRIs in mood disorders, especially as depression is projected to become the leading cause of disability by 2030.
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.
Use of psychedelic treatments in psychiatric clinical practice: an EPA policy paper
European Psychiatry January 1, 2025 Marianne Destoop, Pavel Mohr, Florence Butlen-Ducuing et al. 7 citations
The European Psychiatric Association (EPA) acknowledges the therapeutic potential of psychedelic substances for mental disorders, such as psilocybin for depression, which are nearing regulatory approval in the US and Europe. This policy paper highlights both the benefits and challenges of psychedelic treatments, emphasizing the importance of psychosocial components and ethical, professional aspects for real-world implementation. Four recommendations are formulated to guide further research and clinical integration, aiming for safe, ethical, and equitable access for all patients who may benefit.
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.
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.