| Protocol ID | NCT07063862 |
| Registration Date | 2025-07-14 |
| Status | recruiting |
| Sponsor | Bruyère Health Research Institute. |
| Country | Canada |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2026-01-01 |
| Last Patient Out | 2027-09-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT07063862
PSilocybin Microdose for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site Phase 3 Double-blind, Placebo-controlled, Parallel-arm Clinical Trial
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 6053ms / 14358 tok |
OPENAI
gpt-4o Thinking: o3 4312ms / 12411 tok |
GLM
glm-5.1 7702ms / 12676 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
N/A
early palliative care → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: early palliative care — The study targets patients with advanced illness receiving palliative care regardless of specific disease type, focusing on early integration of palliative care for psychological and existential distress management.
Thinking: N/A — Study targets palliative care patients with various advanced illnesses (2-12 months life expectancy) without focusing on a specific disease category or early integration of palliative care.
|
N/A
N/A → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: early palliative care — The study targets the early integration of palliative care for patients with advanced illness experiencing psychological distress and is not limited to one specific disease.
Thinking: N/A — Population includes mixed advanced illnesses including cancer, so category not applicable.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study targets patients with 'advanced illness' and 'chronic illness' in a palliative care setting, which includes a general and mixed non-cancer population rather than focusing on a specific organ system or single disease category.
|
OK |
| setting_patient | mixed | mixed | mixed | OK |
| setting_place | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — Psilocybin is a pharmaceutical psychedelic medication, not a complementary or alternative medicine modality like acupuncture, aromatherapy, massage, or herbal remedies.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial is focused on psilocybin microdosing, which is a psychedelic medication intervention, not one of the CAM modalities listed such as acupuncture or yoga.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is psilocybin, which is a pharmacological drug and not listed as a complementary and alternative medicine (CAM) modality.
|
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 | OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |