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Cited by 88Psychedelics and Drug StudiesTreatment of Major DepressionCancer survivorship and care

Psilocybin‐assisted group therapy in patients with cancer diagnosed with a major depressive disorder

Open access
Agrawal, Manish, Richards, William, Beaussant, Yvan, Shnayder, Sarah, Ameli, Rezvan, Roddy, Kimberly, Stevens, Norma, Richards, Brian +5 more·2024·Cancer
DOI 10.1002/cncr.35010
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Abstract

Background: Depression is common in patients with cancer and is associated with lower treatment adherence and reduced quality of life. Antidepressants and psychotherapy have limited success in improving depression among patients with cancer. This study explored the safety, feasibility, and efficacy of psilocybin‐assisted therapy in patients with cancer and major depressive disorder. Methods: This phase 2, open‐label trial enrolled patients with curable and noncurable cancer and major depressive disorder at a single community oncology practice site. A single 25‐mg dose of psilocybin was administered simultaneously to cohorts of three to four participants with individual (4.25 hours in 1:1 therapist‐to‐patient ratio) and group therapeutic support (3.75 hours) before, during, and after psilocybin administration. Outcomes included depression severity, anxiety, pain, demoralization, and disability. Results: Thirty participants completed the study. No psilocybin‐related serious adverse events occurred; treatment‐related adverse events (e.g., nausea, headache) were generally mild and expected. There were no laboratory or electrocardiogram abnormalities. No suicidality was reported. Efficacy was suggested with a robust reduction in depression severity scores from baseline to posttreatment of 19.1 points (95% CI, 22.3 to –16.0; p < .0001) by week 8. Eighty percent of participants demonstrated a sustained response to psilocybin treatment; 50% showed full remission of depressive symptoms at week 1, which was sustained for 8 weeks. Conclusions: Psilocybin‐assisted therapy in group cohort administration was safe and feasible in patients with cancer and depression. Efficacy was suggested based on clinically meaningful reductions in depressive symptoms. The novel, group‐oriented format, compact delivery time, community cancer center setting, and one‐to‐one therapist‐to‐patient ratio could also add to therapeutic gains and efficiency of administration. Trial Registration: NCT04593563. Plain Language Summary: Depression is common in patients with cancer and associated with lower treatment adherence, reduced quality of life, and limited response to antidepressants and psychotherapy. We conducted a phase 2 trial to study a single dose of psilocybin administered in a group therapy setting with one‐to‐one therapist‐to‐participant psychological support to patients with curable and noncurable cancer and major depressive disorder. Findings of the study showed safety (no treatment‐related serious adverse events or suicidality) with psilocybin and suggested efficacy, with a significant reduction in depression severity scores from baseline to posttreatment. Further investigation is warranted.

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Crossref · 10.1002/cncr.35010

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  • In the phase 2 trial, there was an absence of serious adverse events (SAEs) or suicidality.

    “Also notable was the absence of serious adverse events (SAEs) or suicidality, as concerns have emerged following reports of SAEs in a recent large trial on psilocybin for treatmentresistant depression.6”

    From Innovations in group-based psilocybin-assisted therapy of major depression in patients with cancer (2024) · cites this paper as [14]

    The Safety section reports no suicidality and no serious adverse events attributed to psilocybin. The citing sentence omits that attribution qualifier, so the paper does not establish an absence of serious adverse events from any cause. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • Racial and/or ethnic diversity of participants was relatively low in the trial in question, similar to other psilocybin studies.

    “Racial and/or ethnic diversity of participants was relatively low in the trial in question, similar to other psilocybin studies, and no information on income was provided.”

    From Innovations in group-based psilocybin-assisted therapy of major depression in patients with cancer (2024) · cites this paper as [14]

    The Discussion identifies a lack of diversity or representation as a limitation, and Table 1 reports that 80% of participants were Caucasian. The paper does not compare its participants’ racial or ethnic diversity with that of other psilocybin studies, so the comparison is not supported by this source. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • In the phase 2 trial, full remission of depressive symptoms was observed in 50% of patients at 8-week follow-up.

    “A sustained response was observed in 80% of patients and full remission of depressive symptoms observed in 50% of patients at 8week follow-up.”

    From Innovations in group-based psilocybin-assisted therapy of major depression in patients with cancer (2024) · cites this paper as [14]

  • Both articles in the current issue are based on a phase 2 open-label trial (N = 30) assessing the impact of single-dose psilocybin on depressive symptoms among patients with cancer and major depressive disorder.

    “Both articles are based on a phase 2 open-label trial (N = 30) assessing the impact of single-dose psilocybin on depressive symptoms among patients with cancer and major depressive disorder.14”

    From Innovations in group-based psilocybin-assisted therapy of major depression in patients with cancer (2024) · cites this paper as [14]

  • The phase 2 trial reported a significant reduction in depression scores from baseline to 8-week follow-up.

    “The study reported a significant reduction in depression scores from baseline to 8-week followup.”

    From Innovations in group-based psilocybin-assisted therapy of major depression in patients with cancer (2024) · cites this paper as [14]

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Authors
Agrawal, M., Richards, W., Beaussant, Y., Shnayder, S., Ameli, R., Roddy, K., Stevens, N., Richards, B., Schor, N., Honstein, H., Jenkins, B., Bates, M., & Thambi, P.
Affiliations
  • Maryland Geological Survey (US)
  • Dana-Farber Cancer Institute (US)
  • Columbia University (US)
  • National Institutes of Health (US)
Corresponding author
Agrawal, Manish
ORCID
Venue
Cancer
Publisher
Wiley
Published
2023-12-18
Volume
130
Issue
7
Pages
1137-1146
ISSN
  • 0008-543X (ISSN-L)
  • 1097-0142
DOI
10.1002/cncr.35010
OpenAlex
W4389900078
Cited by
88
References
42
Citations by year
2026: 34 · 2025: 41 · 2024: 12 · 2023: 1
FWCI
25.55
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Cancer (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
Keywords
psilocybin-assisted therapy, major depressive disorder, cancer patients, group therapy, cancer-related depression, antidepressant resistance, medication adherence, quality of life, adverse events, anxiety, pain, demoralization, disability, psychedelic therapy, community oncology practice, depression remission, feasibility and safety
MeSH terms
Antidepressive Agents, Major Depressive Disorder, Humans, Neoplasms, Psilocybin, Psychotherapy, Group, Quality of Life

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