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Meta-Analysis
. 2023 Sep:327:115349.
doi: 10.1016/j.psychres.2023.115349. Epub 2023 Jul 23.

Assessing the risk of symptom worsening in psilocybin-assisted therapy for depression: A systematic review and individual participant data meta-analysis

Affiliations
Meta-Analysis

Assessing the risk of symptom worsening in psilocybin-assisted therapy for depression: A systematic review and individual participant data meta-analysis

Otto Simonsson et al. Psychiatry Res. 2023 Sep.

Abstract

We conducted a meta-analysis using individual participant data from three, two-dose psilocybin trials for depression (N = 102) with the aim of assessing the risk of symptom worsening. Clinically significant symptom worsening occurred for a minority of participants in the psilocybin and escitalopram conditions (∼10%) and for a majority of participants in the waitlist condition (63.6%). Using data from the two trials with control arms, the psilocybin arm showed a lower likelihood of symptom worsening versus waitlist, and no difference in the likelihood of symptom worsening versus escitalopram. The limitation of a relatively small sample size should be addressed in future studies.

Keywords: Depression; Meta-analysis; Psilocybin.

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Conflict of interest statement

Declaration of Competing Interest The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: OS was a co-founder of Eudelics AB. RCH is a scientific advisor to Synthesis Institute, Osmind, Journey Colab, Maya Health, Mydecine, Beckley Psytech and Mindstate. AKD is a board member of Source Research Foundation and Lead Training at Fluence. DJN is a scientific advisor to COMPASS Pathways who have an interest in psilocybin therapy for depression. He is also chair or PAREA (Psychedelic access and research European alliance) and a member of the UK Drug Science charity's Medical Psychedelic Working Group. DE is a scientific advisor to Clerkenwell Health, Aya Biosciences, Field Trip Health, Mindstate, Pangea Botanica, and Smallpharma LTD. RRG is on the Board of Directors of the Heffter Research Institute. All other authors declare that there is no conflict of interest.

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References

    1. Aday JS, Davis AK, Mitzkovitz CM, Bloesch EK, & Davoli CC (2021). Predicting reactions to psychedelic drugs: A systematic review of states and traits related to acute drug effects. ACS Pharmacology & Translational Science, 4(2), 424–435. - PMC - PubMed
    1. Borenstein M, Cooper H, Hedges L, & Valentine J (2009). Effect sizes for continuous data. The handbook of research synthesis and meta-analysis, 2, 221–235.
    1. Burke DL, Ensor J, & Riley RD (2017). Meta‐analysis using individual participant data: one‐stage and two‐stage approaches, and why they may differ. Statistics in medicine, 36(5), 855–875. - PMC - PubMed
    1. Carhart-Harris RL, Bolstridge M, Rucker J, Day CM, Erritzoe D, Kaelen M, … & Nutt DJ (2016). Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry, 3(7), 619–627. - PubMed
    1. Carhart-Harris RL, Bolstridge M, Day CM, Rucker J, Watts R, Erritzoe DE, … & Nutt DJ (2018). Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology, 235, 399–408. - PMC - PubMed

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