| Protocol ID | NCT05403086 |
| Registration Date | 2022-06-03 |
| Status | recruiting |
| Sponsor | Charles S. Grob, M.D. |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2025-01-19 |
| Last Patient Out | 2027-12-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT05403086
Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5049ms / 10979 tok |
OPENAI
gpt-4o Thinking: o3 6480ms / 9429 tok |
GLM
glm-5.1 6528ms / 9639 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
N/A → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: early palliative care — This study targets adults near the end of life with any life-threatening illness receiving palliative care, representing early integration of palliative care across multiple disease types rather than focusing on one specific condition.
Thinking: N/A — Study includes mixed palliative care population with ≤2 years life expectancy without focusing on a specific disease category.
|
N/A
early palliative care → N/A → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: N/A — The study focuses on demoralization in a mixed or general population with life-threatening conditions without specifying a non-cancer category.
Thinking: N/A — Population includes adults with any life-threatening illness near end of life (mixed cancer and non-cancer), so no single non-cancer category applies.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study targets adults near the end of life with a life-threatening illness and is disease-agnostic rather than focusing on a single specific non-cancer condition.
|
OK |
| setting_patient | outpatient | outpatient | outpatient | 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 | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | yes | yes | yes | OK |
| intervention_complex | yes | yes | yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This study tests psilocybin therapy as a pharmacologic intervention for demoralization in palliative care patients, making palliative care the setting rather than the intervention being tested.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial tests psilocybin therapy versus ketamine, not a palliative care intervention.
|
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
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 |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes focus on psychological symptoms (demoralization, depression, anxiety), quality of life measures, spiritual well-being, and pain - which all fall within the symptom/QoL categories.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All specified primary and secondary outcomes focus on symptom management, including demoralization, depression, anxiety, and quality of life, which fall within the symptom/QoL/dignity categories.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary and secondary outcomes measure symptoms, quality of life, or spiritual well-being, which fall under the symptom/QoL categories.
|
OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |