| Protocol ID | NCT04593563 |
| Registration Date | 2020-10-20 |
| Status | Unknown Status |
| Sponsor | Maryland Oncology Hematology, PA |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-09-01 |
| Last Patient Out | 2023-10-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04593563
The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
| Field |
GLM
glm-5.1 13120ms / 10355 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5310ms / 11912 tok |
OPENAI
gpt-4o Thinking: o3 3191ms / 10197 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 | 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
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial specifically measures psycho-social-spiritual healing using the NIH-HEALS (National Institute of Health Healing Experience of All Life Stressors) outcome.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study includes the NIH-HEALS (National Institute of Health Healing Experience of All Life Stressors) as a primary outcome, which is a psycho-social-spiritual healing measure that assesses positive transformation in response to challenging life events and includes spiritual dimensions of healing.
Thinking: yes — The study includes DS-II, which appears to be the Demoralization Scale that specifically measures existential distress.
|
yes
no → no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial focuses on depression and anxiety outcomes without specific measures for dignity, existential distress, or spiritual well-being.
Thinking: yes — Includes DS-II Demoralization Scale and NIH-HEALS, instruments assessing existential and spiritual well-being.
|
OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |