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Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects
Drummond E-Wen McCulloch1, Matthias E Liechti2, Kim Pc Kuypers3
1Neurobiology Research Unit, Rigshospitalet, University of Copenhagen, Denmark.
Neuroscience Applied
|July 14, 2025
Summary
Psychedelic medicines show promise for psychiatric conditions like depression. Further research is needed on pharmacokinetics, pharmacodynamics, and psychological support for safe and effective clinical implementation.
Area of Science:
- Neuroscience
- Psychopharmacology
- Clinical Medicine
Background:
- Psychedelic drugs, including psilocybin and LSD, are being investigated for psychiatric and neurological disorders.
- Phase 2 trials indicate significant potential for these substances in treating depression.
Purpose of the Study:
- Identify critical knowledge gaps for the medical implementation of psychedelic drugs.
- Synthesize expert perspectives from the European College of Neuropsychopharmacology.
Main Methods:
- Discussion and consensus-building among European College of Neuropsychopharmacology members at the New Frontiers Meeting (2023).
- Focus on key themes relevant to regulatory and clinical adoption.
Main Results:
- Key knowledge gaps identified in pharmacokinetic and pharmacodynamic characterization.
- Need for comparative studies between different psychedelics.
- Understanding the relationship between subjective effect duration and therapeutic outcomes.
- Investigating polypharmacology and the role of psychological support.
Conclusions:
- Expert consensus highlights essential requirements for psychedelic medicine implementation in Europe.
- European Medicines Agency and Health Technology Assessors perspectives emphasize pressing needs for regulatory approval and clinical integration.
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