amyotrophic lateral sclerosis (ALS), and atypical Parkinson disorder (APD), and corticobasal syndrome (CBS)., Chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), particularly multiple system atrophy (MSA), progressive supranuclear palsy (PSP)
Conditions
Brief summary
The primary endpoint is the change in depressive symptoms from baseline to 6 weeks after the second dose of psilocybin (high dose session) compared low-dose control..
Detailed description
To assess change in clinical functioning, end-of-life anxiety, psychological/existential distress, health-related quality of life, and how it impacts caregiver ’s health- and economic burden.
Interventions
DRUGPsilocybin capsules 1 mg
DRUGPsilocybin capsules 15 mg
DRUGPsilocybin capsules 25 mg
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in depressive symptoms from baseline to 6 weeks after the second dose of psilocybin (high dose session) compared low-dose control.. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess change in clinical functioning, end-of-life anxiety, psychological/existential distress, health-related quality of life, and how it impacts caregiver ’s health- and economic burden. | — |
Countries
Czechia, Denmark, Netherlands, Portugal
Outcome results
None listed