| Protocol ID | NCT06818994 |
| Registration Date | 2025-02-11 |
| Status | recruiting |
| Sponsor | Gustavo Vazquez |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2026-04-01 |
| Last Patient Out | 2027-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 70 Years |
NCT06818994
Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer: a Pilot Study
| Field |
CLAUDE
claude-sonnet-4-20250514 5193ms / 11044 tok |
OPENAI
gpt-4o 5642ms / 9521 tok |
GLM
glm-5.1 10059ms / 9681 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | 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 | 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
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is psilocybin-assisted psychotherapy for demoralization syndrome, which is a pharmacological/psychotherapeutic intervention being tested in cancer patients, not palliative care consultation or service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial investigates psilocybin-assisted psychotherapy for demoralization, not a palliative care intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is psilocybin-assisted psychotherapy (a pharmacological and psychological treatment) in a palliative care population, not palliative care itself.
|
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 | no | no | no | 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 |