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Evidence memo

Psilocybin-assisted therapy

Also tracked as: Psilocybin therapy, COMP360

A structured investigational therapy model with randomized depression data, but no broad approval and major implementation questions.

Randomized human data Investigational Safety watch

Evidence status

Watch closely. Evidence level: Randomized human data.

Claim being evaluated

Whether psilocybin plus structured psychological support can deliver durable benefits with acceptable safety in defined psychiatric populations.

Why people care

Early depression results and cultural attention have made psilocybin a leading psychedelic research story.

Signal so far

Randomized human data exist in depression contexts. Results depend heavily on study design, support model, comparator, blinding, and follow-up.

Biggest unknown

Durability, rare harms, therapist/support infrastructure, patient selection, regulatory requirements, and real-world generalizability.

Safety/regulatory boundary

Investigational therapy evidence is not approval, availability, or self-use guidance.

Watch next

Phase 3 outcomes, regulatory decisions, risk mitigation requirements, and implementation standards.

Evidence interpretation

One of the most important psychiatric pipeline areas, but still not a consumer wellness category.

References