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Psychedelic-Assisted Therapy
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# Psychedelic-Assisted Therapy Portal: Mind & Cognition Stage: Late-stage trials, approval contested Evidence: Early human Template: Intervention Risk: Moderate Reversibility: Reversible Last reviewed: May 2026 == Summary == Psilocybin and MDMA paired with therapy show promise for depression and PTSD in trials, but regulatory approval, durability, and trial design remain unsettled. == Key takeaways == * Trials pair a psychedelic with structured psychotherapy, not a drug alone. * Results in depression and PTSD are promising but face blinding and durability questions. * Regulatory approval has been uneven, underscoring unsettled evidence. == The approach == Psychedelic-assisted therapy combines a supervised dose of a compound such as psilocybin or MDMA with preparatory and integration psychotherapy. Trials in treatment-resistant depression and PTSD have reported meaningful improvements for many participants. The model treats the drug as a catalyst for therapy rather than a stand-alone medication, which complicates comparison with conventional drug trials. == Why it is still early == Blinding is hard when participants can tell whether they received a psychedelic, and expectancy may inflate effects. Durability, optimal dosing, and safety in broader populations are not fully established. Regulators have not uniformly accepted the evidence — at least one high-profile application was rejected pending stronger data — which keeps the field in the early-human, not established-practice, column. == Open questions == * How much of the benefit survives rigorous blinding? * How long do effects last, and for whom is it unsafe? == Watchlist == * Blinding-robust trials * Durability data * Regulatory decisions == References == * MDMA-assisted therapy for PTSD (phase 3) — Mitchell et al., Nature Medicine, 2021. https://pubmed.ncbi.nlm.nih.gov/33972795/. Phase 3 trial reporting benefit for severe PTSD. * Psilocybin vs escitalopram for depression — Carhart-Harris et al., NEJM, 2021. https://www.nejm.org/doi/full/10.1056/NEJMoa2032994. Head-to-head trial of psilocybin therapy in depression. == Categories == [[Category:Mind & Cognition]] [[Category:psilocybin]] [[Category:MDMA]] [[Category:mental health]]