A review of psychedelics trials completed in depression, informed by European regulatory perspectives.

ABSTRACT: There is a growing body of clinical research on the therapeutic potential of psychedelics for the treatment of mental health disorders, notably depression. Accordingly, the new revision of the European Medicines Agency guideline on the clinical investigation of products for depression will incorporate a section covering specific regulatory recommendations for the design of studies with psychedelics. The present review investigated the methodological approaches adopted in completed controlled trials of psychedelics for depression in light of initial considerations included in the draft guideline revision. A systematic search conducted on scientific databases (Embase and Medline) and clinical trial registries (clinicaltrials.gov and WHO ICTPR) identified 8 completed trials as of February 202

SUBMITTER: Silva F 

PROVIDER: S-EPMC12244136 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature