| Protocol ID | NCT04754061 |
| Registration Date | 2021-02-15 |
| Status | recruiting |
| Sponsor | Ottawa Hospital Research Institute |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2024-01-08 |
| Last Patient Out | 2025-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04754061
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
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 6020ms / 13663 tok |
OPENAI
gpt-4o Thinking: o3 6237ms / 11889 tok |
GLM
glm-5.1 11139ms / 12062 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
early palliative care
early palliative care → early palliative care
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: early palliative care — This study targets patients with advanced illness under palliative care management (1-12 months life expectancy) across multiple disease types, focusing on early integration of palliative care for psychological and existential distress rather than being disease-specific.
|
early palliative care
early palliative care → early palliative care
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: early palliative care — The trial targets early integration of palliative care focused on psychological distress and existential distress in patients with advanced illness, not limited to a specific disease.
|
early palliative care
N/A → early palliative care
shaky reasoning✓ Unanimous
Initial: N/A
Requery: early palliative care — The study targets patients with advanced illness under palliative care management (not limited to one specific organ system), focusing on early intervention for psychological and existential distress using psilocybin microdosing.
|
OK |
| setting_patient | mixed | mixed | mixed | OK |
| setting_place | other | other | other | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | yes | yes | yes | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study includes feasibility metrics (recruitment rate, intervention completion rate, follow-up completion rate) as primary outcomes, which are not covered by symptom/QoL/dignity/cost categories.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial measures feasibility metrics, particularly focused on recruitment, intervention, and follow-up completion rates, which are outcomes not covered by symptom/QoL/dignity/cost categories.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial includes feasibility metrics (e.g., recruitment rate, intervention/follow-up completion rates) as primary outcomes, which are not covered by the symptom/QoL/dignity/cost categories.
|
OK |
| pharmacologic_sub |
not yet FDA/EMA approved
controlled substances → controlled substances → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: controlled substances
Requery: controlled substances — Psilocybin is a controlled substance as it is a psychedelic/hallucinogenic compound with controlled legal status and potential for abuse.
Thinking: not yet FDA/EMA approved — Psilocybin is an experimental/investigational drug in Phase I/II trials that has not yet received FDA/EMA approval for any medical indication.
|
not yet FDA/EMA approved
controlled substances → not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: controlled substances
Requery: not yet FDA/EMA approved — Psilocybin is being used experimentally in this trial and is not yet approved by the FDA or EMA for this indication.
Thinking: not yet FDA/EMA approved — Psilocybin is an investigational psychedelic that is not commercially approved by the FDA or EMA for any indication.
|
not yet FDA/EMA approved
not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: not yet FDA/EMA approved
|
OK |