Evidence map›Paper›PMID 41617652›Full record

Trial reportPalliative medicine2026

PSilocybin for psYCHological and existential distress in PALliative care (PSYCHED-PAL): A single arm unblinded clinical trial.

James Downar, Julie Lapenskie, Koby Anderson, Gaelle Parsons, Nadia Polskaia, Genevieve Lalumiere, Peter Lawlor

Registry-linked trialAbstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in Palliative medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04754061 (PSilocybin for psYCHological and Existential Distress in PALliative Care), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04754061 phase1 / phase2active not recruitingnot on this map

PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Clinical Trial

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2024 to 2027Enrolled20ConditionsDepression, Anxiety, Distress, EmotionalArmsPsilocybin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

James DownarDepartment of Medicine, University of Ottawa, Canada.ORCID 0000-0001-7479-1560
Julie LapenskieDepartment of Medicine, University of Ottawa, Canada.ORCID 0000-0002-5358-5685
Koby AndersonBruyère Health Research Institute, Ottawa, Canada.
Gaelle ParsonsBruyère Health Research Institute, Ottawa, Canada.
Nadia PolskaiaBruyère Health Research Institute, Ottawa, Canada.
Genevieve LalumiereBruyère Health Research Institute, Ottawa, Canada.
Peter LawlorDepartment of Medicine, University of Ottawa, Canada.ORCID 0000-0001-7319-1395

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsychological distress is a common problem near the end of life, for which we lack effective, timely and scalable treatments. No previous study has assessed whether microdose psilocybin can improve symptoms in this population.

aimTo determine whether microdose psilocybin is safe, feasible and potentially efficacious in a palliative setting.

designOpen label, single-arm clinical trial of a 3-week oral psilocybin intervention, starting with 1 mg daily in week 1, increased to 2 mg in week 2 and 3 mg in week 3. CLINICALTRIALS: gov NCT04754061. SETTING/

participantsTwo-center study in Ottawa, Canada of adults with advanced, incurable illness and an estimated prognosis of 1-12 months, experiencing severe psychological distress.

resultsWe enrolled 20 participants (59% of those screened) between January 2024 and April 2025, of which 17 began and 13/17 (76%) completed the intervention. Participants were 40-84 years old, 53% female, and 82% had cancer. There were no serious adverse events reported, and nine mild or moderate adverse events. Four participants withdrew due to disease progression or poor response. Of the 13 remaining participants, nine (69%) reported a meaningful global improvement (Patient Global Impression of Change ⩾ 5); 8 (62%) reported >50% improvement in Hamilton Depression Rating Scale scores, 7 (54%) reported >50% improvement in Hospital Anxiety and Depression Scale scores and 9 (72%) reported a meaningful improvement in Demoralization Scale II scores.

conclusionsMicrodose psilocybin is a safe, feasible and potentially efficacious treatment for psychological distress in people with advanced illness.

Indexed as

ExistentialismHallucinogensPalliative CarePsilocybinPsychological DistressStress, PsychologicalAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedTreatment OutcomeHallucinogensPsilocybinanxietydepressionend of life careexistential distresspalliative carepsilocybinpsychedelic agents

Identifiers

PMID41617652
PMCPMC13062460

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.