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Evolution and Comparative Analysis of Clinical Trials on Psilocybin in the Treatment of Psychopathologies: Trends in the EU and the US

Summary

Researchers are studying psilocybin, a compound from certain mushrooms, as a potential treatment for depression, anxiety, and addiction. The United States has significantly more clinical trials underway than the European Union, reflecting different regulatory approaches and funding levels. While US trials progress faster, EU trials emphasize safety and careful evaluation. Both regions show promising results when psilocybin is combined with professional psychological support in controlled settings.

Background

Over the past two decades, psilocybin has emerged as a promising therapeutic compound for treating various mental disorders. The scientific community has begun re-evaluating this previously stigmatized substance, with growing institutional approvals in both the United States and European Union for clinical research exploring its therapeutic potential.

Objective

This study examines the development of clinical trials investigating psilocybin for treating psychopathologies with comparative focus on the United States and European Union. The objective is to identify regional differences in trial progression, research infrastructure, and regulatory frameworks.

Results

The US demonstrated 149 psilocybin trials compared to 18 in the EU, with over 6,000 volunteers in US trials versus 1,800 in EU trials. The US showed more permissive approval ecosystems with greater presence of Phase 0 studies, while the EU demonstrated more conservative progression focusing on participant safety. Geographic concentration was highest in California, Maryland, and Connecticut in the US, and France, Denmark, and Czech Republic in the EU.

Conclusion

This analysis highlights uneven pacing of psilocybin research across regions driven by regulatory, funding, and sociocultural differences. International collaboration and harmonization of public health policies are essential to ensure scientific rigor and patient protection while expanding treatment options for mental health disorders.
  • Published in:Journal of Clinical Medicine,
  • Study Type:Comparative Analysis and Systematic Review,
  • Source: 41010814
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