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Single-Dose Psilocybin for Depression With Severe Treatment Resistance: An Open-Label Trial

Scott T Aaronson, Andrew van der Vaart, Tammy Miller, Jeffrey LaPratt, Kimberly Swartz, Audrey Shoultz, Margo Lauterbach, Trisha Suppes, Harold A Sackeim

American Journal of Psychiatry 2025 DOI: 10.1176/appi.ajp.20231063 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Open-label study Peer reviewed
Population People with severe treatment-resistant depression
Intervention Psilocybin
Topics Depression Psilocybin
Keywords Psychedelics hallucinogens Psychedelic drugs Drug research Clinical trials Clinical drug studies Depressive disorders Drug/psychotherapy combination Psychopharmacology
Citations 31
Key points Psilocybin suggests efficacy and safety in severe treatment-resistant depression and supports further study, including consideration of PTSD interaction effects.

Abstract

This open-label study suggests efficacy and safety of psilocybin in severe TRD and supports further study of psychedelics in this population, including consideration of PTSD interaction effects.

Comparable studies

Other non-randomized and open-label trials on psilocybin for depression, most cited first.

Study Year Design Participants
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Patients with moderate-to-severe, unipolar, treatment-resistant major depression 2016 Open-label feasibility trial n = 12
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression 2017 Open-label trial n = 20
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Patients with major depressive disorder 2021 Open-label study n = 24
Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression. Individuals diagnosed with moderate to severe, treatment-resistant depression 2017 Open-label study n = 20

Citations in the library

Cited by 30

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Depression Psilocybin PTSD

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