Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injury
Conditions
Brief summary
Co-primary outcomes 1: Number of patients with improved consciousness within 3-6h after a single dose of oral psilocybin with/without apomorphine vs. placebo (as measured by a composite score of either FOUR score ≥2 and/or SECONDs ≥1, Co-primary outcome 2: Number of patients with improved consciousness levels within 3-6h after oral psilocybin/apomorphine vs. psilocy-bin/placebo
Detailed description
Pupillary function (pupillometry, including spontaneous pupillary function and during a mental arithmetic paradigm), Neurovascular coupling (NIRS-EEG, including spontaneous cortical activity and activation during a tongue motor imagery paradigm) at days 1 and 7, Clinical outcome at day 90 (GOS-E), Days alive outside the ICU, Serious adverse reactions (SARs), Serious adverse events
Interventions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary outcomes 1: Number of patients with improved consciousness within 3-6h after a single dose of oral psilocybin with/without apomorphine vs. placebo (as measured by a composite score of either FOUR score ≥2 and/or SECONDs ≥1, Co-primary outcome 2: Number of patients with improved consciousness levels within 3-6h after oral psilocybin/apomorphine vs. psilocy-bin/placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Pupillary function (pupillometry, including spontaneous pupillary function and during a mental arithmetic paradigm), Neurovascular coupling (NIRS-EEG, including spontaneous cortical activity and activation during a tongue motor imagery paradigm) at days 1 and 7, Clinical outcome at day 90 (GOS-E), Days alive outside the ICU, Serious adverse reactions (SARs), Serious adverse events | — |
Countries
Denmark
Outcome results
None listed