Abstract
Psilocybin-assisted psychotherapy (PAP) has shown promise in treating mood and anxiety disorders in patients with cancer. However, patients with cancer often suffer from more than just depression and anxiety, and so far, PAP’s effect on other psychiatric symptoms remains largely unknown. To address this gap, we pooled previously unpublished data from two phase II, randomized, placebo-controlled crossover trials involving 79 participants with cancer-related distress and analyzed PAP’s effect on 9 psychiatric symptom dimensions: anxiety, depression, interpersonal sensitivity, hostility, obsession–compulsion, somatization, phobia, paranoia and psychosis. PAP significantly improved anxiety, depression, interpersonal sensitivity, hostility, obsession–compulsion and somatization without inducing any lasting phobia, paranoia or psychosis. Clinical improvements were consistent between trials. Together, our findings suggest that PAP has the potential to be a comprehensive mental health treatment for patients with cancer.
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Data availability
The clinical trial participants of both studies used in this Analysis did not consent to the public sharing of their raw data. However, anonymized individual participant data can be made available provided the following conditions are met: (1) there is a data-sharing agreement and (2) an analysis plan in place. Upon data sharing, data can only be used for the specified purposes. Requests for data can be made by contacting the corresponding author.
Code availability
There was no custom code used in this Analysis.
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Acknowledgements
The parent trials included in this Analysis were supported by grants from the Heffter Research Institute (R.R.G. and S.R.), the RiverStyx Foundation (R.R.G. and S.R.), the Betsy Gordon Foundation (R.R.G.), the Fetzer Institute (R.R.G.) and the New York University–Health and Hospitals Corporation–Clinical and Translational Science Institute grant UL1 TR000038 from the National Center for Advancing Translational Sciences, National Institutes of Health (NIH) (S.R.). Additional funding for the parent trials was provided by Carey and Claudia Turnbull (S.R.), W. Linton (R.R.G. and S.R.), R. Barnhart (S.R.), A. Altschul (S.R.), K. Fitzsimmons (S.R.), the McCormick Family (R.R.G.), G. Goldsmith (R.R.G. and S.R) and E. Malievskaia (R.R.G. and S.R.). Funding for the pooled analysis was provided by the Usona Institute scholarship (P.D.P), the NIH T32DA007250 (G.A.-L.) and the Canadian Institutes of Health Research (grant number 202110MFE-472921-HTB-272687) (R.J.Z.). Sponsors did not have roles in the management, analysis or interpretation of the data, nor in the preparation or approval of the manuscript.
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Contributions
P.D.P. and S.R. conceived of the analysis. R.R.G. and S.R. provided deidentified individual participant data from their respective parent clinical trials. P.D.P. analyzed the data with support from J.G. and M.P.B. P.D.P., J.G., G.A.-L., C.J.K., R.J.Z., M.P.B., R.R.G. and S.R. interpreted the results of the analysis. P.D.P. wrote the paper. P.D.P., J.G., G.A.-L., C.J.K., R.J.Z, M.P.B., R.R.G. and S.R. critically revised the article.
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R.J.Z. is a post-doctoral fellow in the NYU Langone Psychedelic Medicine Research Training program funded by MindMed. M.P.B. is principal investigator of the NYU Langone Center for Psychedelic Medicine Research Training Program, funded by MindMed. M.P.B. has received research funding from Tilray Canada, the Multidisciplinary Association for Psychedelic Studies (MAPS) PBC, B.More Inc., the Heffter Research Institute, the Turnbull Family Foundation, the Fournier Family Foundation, Dr. Bronner’s Family Foundation, Bill Linton and the Riverstyx Foundation. M.P.B. serves on the Advisory Board of Ajna Labs LLC, Journey Colab and Bright Minds Biosciences, Inc. He is named as inventor on patent applications relating to the use of psilocybin for alcohol use disorder but has waived all rights and has no prospect of financial benefit. S.R. is the Director of NYU Langone Center for Psychedelic Medicine Research Training Program, which is funded by MindMed. S.R. currently receives, or has received in the past 36 months, grant support for clinical research from the National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), Heffter Research Institute, Usona Institute, Council on Spiritual Practices (CSP), Multidisciplinary Association of Psychedelic Studies (MAPS) and Reset Pharmaceuticals. S.R. is listed as a coinventor in two provisional patent applications (N420838US and N419987US) related to the use of psilocybin to treat psychiatric and existential distress in cancer. These provisional patent applications were filed by New York University Grossman School of Medicine and licensed by Reset Pharmaceuticals. S.R. has waived all rights in relation to these provisional patent applications and has no prospect of financial gain related to any future commercialization efforts related to these patents. The other authors declare no competing interests.
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Petridis, P.D., Grinband, J., Agin-Liebes, G. et al. Psilocybin-assisted psychotherapy improves psychiatric symptoms across multiple dimensions in patients with cancer. Nat. Mental Health 2, 1408–1414 (2024). https://doi.org/10.1038/s44220-024-00331-0
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DOI: https://doi.org/10.1038/s44220-024-00331-0
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