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Life sciences · Journal article
Pharmacotherapy in Psychiatry and Neurology · September 29, 2026
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Psilocybin, a classical serotonergic psychedelic, has become the subject of intensive clinical and translational research in psychiatry.This review focuses primarily on treatment-resistant depression (TRD), the indication with the most advanced level of clinical evidence and the one closest to potential regulatory approval, while other indications -major depressive disorder without documented treatment resistance, cancer-related anxiety and depression, and substance use disorders -are discussed more briefly.The aim of this review is to summarize current evidence regarding the mechanisms of action, clinical efficacy, safety, methodological limitations, and translational perspectives of psilocybin, based on PubMed-indexed literature through July 2026.The strongest clinical evidence concerns TRD, where a phase IIb trial and two phase 3 trials of the COMP360 program demonstrated significant symptom reduction after one or two administrations; in parallel, the independent German EPISODE trial provided data suggesting the need for a two-dose treatment cycle and raised safety signals regarding suicidal ideation and hallucinogen persisting perception disorder (HPPD) that warrant further validation and close clinical monitoring.Increasing attention is directed toward biological mechanisms beyond 5-HT2A receptor agonism, including neuroplasticity and BDNF/mTOR signaling -partly shared with the mechanism of ketamine and esketamine.The review also discusses a clinical implementation model resembling that used for esketamine administration, based on supervised dosing in certified centers, alongside a concrete European organizational precedent: Germany's compassionate use programme for psilocybin in TRD, the first of its kind in the European Union.Emerging translational approaches involving digital technologies, virtual reality, biofeedback, and controlled therapeutic environments are discussed, with particular relevance to hospital-based psychiatric settings.Important limitations remain, including small sample sizes, difficulties in maintaining blinding, heterogeneity of psychotherapeutic protocols, and a lack of long-term follow-up.Current evidence supports further investigation of psilocybin for treatment-resistant depression, but remains insufficient to establish it as a standard psychiatric treatment outside strictly controlled clinical and research settings.