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.

Extracted Fields (from Registry)
Protocol IDNCT06782724
Registration Date2025-01-20
Statusnot yet recruiting
SponsorUniversity Medical Center Groningen
Country
Industrynot industry
Blindingblinded
Center Type
Scope
First Patient In2025-03-01
Last Patient Out2028-01-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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