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

Extracted Fields (from Registry)
Protocol IDNCT07063862
Registration Date2025-07-14
Statusrecruiting
SponsorBruyère Health Research Institute.
CountryCanada
Industrynot industry
Blindingblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2026-01-01
Last Patient Out2027-09-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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