| Protocol ID | NCT06782724 |
| Registration Date | 2025-01-20 |
| Status | not yet recruiting |
| Sponsor | University Medical Center Groningen |
| Country | – |
| Industry | not industry |
| Blinding | blinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2025-03-01 |
| Last Patient Out | 2028-01-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT06782724
The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients with COPD, ALS, MS, or APD.
| Field |
GLM
glm-5.1 11551ms / 14149 tok |
CLAUDE
claude-sonnet-4-20250514 6007ms / 16227 tok |
OPENAI
gpt-4o 4891ms / 13905 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 → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study includes a mixed population of patients with various non-cancer conditions (COPD, ALS, MS, and APD) rather than focusing on a single specific organ system or disease category.
|
N/A
neurodegenerative → N/A
shaky reasoning✓ Unanimous
Initial: neurodegenerative
Requery: N/A — This study targets a mixed population of four different specific disease conditions (COPD, ALS, MS, APD) rather than focusing on one specific disease category or early palliative care integration.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study includes a specific combination of conditions (COPD, ALS, MS, APD) without focusing on early integration of palliative care or one specific non-cancer condition.
|
OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
hospital
shaky reasoning✓ Unanimous
Initial: hospital
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The psilocybin therapy sessions take place in specialized treatment rooms at the University Medical Center Groningen designed for this therapy, which represents an outpatient clinical research facility rather than traditional inpatient hospital care.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is conducted in a controlled safety environment within a treatment room specifically designed for psilocybin therapy, not requiring hospital admission or being categorized as hospice, nursing home, or home care.
|
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 — The trial tests psilocybin drug therapy in palliative care patients, where palliative care is the setting, not the intervention being studied.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is psilocybin therapy (a pharmacologic/psychedelic treatment) tested in patients with life-limiting conditions, not palliative care service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is psilocybin therapy, not palliative care as the intervention itself.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The core intervention is in-person psilocybin therapy, with the digital care platform serving only as an exploratory adjunct and optional peer support during the follow-up period.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary intervention is psilocybin therapy delivered through in-person preparation, dosing, and integration sessions with therapists, while the digital care platform is only mentioned as supplementary access during follow-up and not central to the therapeutic intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary intervention in the trial is psilocybin therapy, and the digital care platform is only mentioned as part of the long-term follow-up, not as a core component of the intervention itself.
|
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 | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |